publications

Nov. 24, 2025 – onasemnogene abeparvovec-brve (Itvisma)

Biologics License Application (BLA) approval; Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review; active ingredient in Itvisma is identical to that of onasemnogene abeparvovec-xioi (Zolgensma) but at a different concentration that is administered intrathecally versus intravenously
Adeno-associated virus (AAV) vector-based gene therapy
Indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients ≥ 2 years of age with confirmed mutation in survival motor neuron 1 (SMN1) gene
Suspension for intrathecal injection: 1.2 × 10¹⁴ vector genomes (vg) in 3 mL in each single-dose vial (nominal concentration of 4 × 10¹³ vg/mL); each vial contains an extractable volume of not less than 3 mL
Recommended dosage is 1.2 × 10¹⁴ vg administered as a single one-time dose via intrathecal bolus injection over approximately one to two minutes administered by a trained health care professional (HCP); starting one day prior to the injection, systemic corticosteroids are required for at least 30 days, depending on liver function by clinical examination and laboratory testing; do not abruptly stop corticosteroids
Approval was based on a 3:2 ratio randomized, double-blind, sham-controlled study (STEER; n=136) that demonstrated a statistically significant improvement in the Hammersmith Functional Motor Scale – Expanded (HFMSE) score at the end of follow-up (average of week 48 and 52 assessment) with onasemnogene abeparvovec-brve (2.39) compared to sham (0.51; treatment difference, 1.88; 95% confidence interval [CI], 0.51 to 3.25; p=0.0074); HFMSE evaluates motor function in patients with SMA who have limited ambulation, with higher scores representing better motor function (maximum total score 66)
Onasemnogene abeparvovec-xioi (Zolgensma) is also an AAV vector-based gene therapy but is indicated for the treatment of pediatric patients < 2 years of age with SMA with bi-allelic mutations in the SMN1 gene and is given as a single-dose intravenous (IV) infusion; other FDA-approved therapies for SMA include nusinersen (Spinraza), a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide (ASO) administered intrathecally for SMA in pediatric and adult patients, and risdiplam (Evrysdi), an SMN2 splicing modifier taken orally (solution/tablets) for SMA in pediatric and adult patients
Boxed warning for serious liver injury
Itvisma is available from Novartis Gene Therapies

Nov. 25, 2025 – sibeprenlimab-szsi (Voyxact)

BLA approval; Accelerated Approval, Breakthrough Therapy, Priority Review
A proliferation inducing ligand (APRIL) blocker
Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression; Accelerated Approval based on reduction in proteinuria; not established whether slows kidney function decline over the long-term; continued approval may require demonstration of benefit in a confirmatory clinical trial
Solution for injection: 400 mg/2 mL (200 mg/mL) in a single-dose prefilled syringe
Recommended dosage is given as a subcutaneous (SC) injection once every four weeks; patients/caregivers can administer following proper training
Approval was based on a randomized, double-blind, placebo-controlled trial (VISIONARY; n=320 in prespecified interim analysis) that demonstrated the relative change from baseline in the urine protein/creatinine ratio based on 24-hour urine collections (uPCR-24h) at month nine was significantly improved with sibeprenlimab-szsi compared to placebo (difference in estimated percent change of 51% versus placebo; p<0.001)
Other FDA-approved therapies for IgAN include (1) the corticosteroid budesonide (Tarpeyo), a delayed release oral corticosteroid indicated to reduce the loss of kidney function in adults at risk for disease progression, (2) sparsentan (Filspari), an oral endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults at risk for disease progression and both (3) iptacopan (Fabhalta), an oral complement factor B inhibitor, and (4) atrasentan (Vanrafia), an oral endothelin receptor antagonist, which are indicated to reduce proteinuria in adults at risk for disease progression (Accelerated Approval for both)
Voyxact is available from Otsuka

Dec. 9, 2025 – etuvetidigene autotemcel (Waskyra)

BLA approval; Orphan Drug, Rare Pediatric Disease, Regenerative Medicine Advanced Therapy
Autologous hematopoietic stem cell (HSC)-based gene therapy
Indicated for the treatment of pediatric patients ≥ 6 months of age and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available
Suspension for injection: packaged in one to eight infusion bags containing a suspension of 2 to 11.4 x 10⁶ cells/mL (1.9 to 11.4 x 10⁶ CD34+ cells/mL) in a cryopreservative solution; for autologous use only (patients undergo hematopoietic stem and progenitor cell mobilization followed by apheresis to obtain CD34+ cells for manufacturing of the product)
Recommended dosage is a minimum of 7 x 10⁶ CD34+ cells per kg administered IV by an HCP; reduced-intensity conditioning is required prior to the infusion
Approval was based on two open-label, single-arm, multinational clinical studies and an expanded access program (n=27 total); etuvetidigene autotemcel demonstrated a reduction in the rate of severe infections from two infections per patient year observation (PYO) in the 12 months pre-treatment to 0.2 per PYO in the six to 18 months post-gene therapy; the rate of moderate and severe bleeding events also decreased from two events per PYO in the 12 months pre-treatment to 0.8 events per PYO in the 12 months after treatment
Prior to approval of Waskyra, patients with WAS received symptomatic management and allogeneic HSCT which required a matched donor; Waskyra is the first gene therapy for WAS and is prepared from modification of the patient’s own HSC genetically modified to include functional copies of the WAS gene
Waskyra is expected to be available from Fondazione Telethon with timeframe to be determined (TBD)

Dec. 16, 2025 – depemokimab-ulaa (Exdensur)

BLA approval; first ultra-long-acting biologic with twice per year dosing for patients with severe asthma with an eosinophilic phenotype
Interleukin-5 (IL-5) antagonist
Indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age; not indicated for relief of acute bronchospasm or status asthmaticus
Solution for injection: 100 mg/mL in a single-dose prefilled pen and single-dose prefilled syringe with needle guard
Recommended dosage is administered once every six months by SC injection into the upper arm, thigh or abdomen by an HCP
Approval was based on data from two randomized, placebo-controlled phase 3 trials (SWIFT-1 and SWIFT-2; n=762 total); depemokimab-ulaa demonstrated a significant decrease in the rate of asthma attacks compared with placebo over 52 weeks (SWIFT-1: 58% reduction; SWIFT-2: 48% reduction) corresponding with rate ratios of 0.42 (p<0.001) and 0.52 (p<0.001), respectively
Other similar FDA approved agents include (1) the IL-5 receptor alpha-directed cytolytic monoclonal antibody benralizumab (Fasenra) (indicated for ≥ 6 years of age), (2) the IL-5 antagonist monoclonal antibody reslizumab (Cinqair) (indicated for ≥ 18 years of age) and (3) the IL-5 antagonist monoclonal antibody mepolizumab (Nucala) (indicated for ≥ 6 years of age)
Exdensur is available from GlaxoSmithKline

Dec. 19, 2025 – aficamten (Myqorzo)

New Drug Application (NDA) approval; Breakthrough Therapy, Orphan Drug
Cardiac myosin inhibitor
Indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms
Film-coated tablets: 5 mg, 10 mg, 15 mg, 20 mg
Recommended starting dosage is taken orally once daily with or without meals at about the same time every day; dosage is increased every two to eight weeks until a maintenance dose or the maximum dose is reached; maintenance dosage should be individualized based on echocardiographic assessments and clinical status
Approval was based on a double-blind, randomized, Phase 3 clinical trial (SEQUOIA-HCM; n=282) that evaluated the change from baseline to week 24 in peak oxygen uptake as assessed by cardiopulmonary exercise testing; at week 24, the average change in the peak oxygen uptake was 1.8 mL/kg/minute (95% CI, 1.2 to 2.3) in the aficamten-treated patients compared with 0 mL/kg/min (95% CI, -0.5 to 0.5) in the placebo group (p<0.001)
Mavacamten (Camzyos) is also a cardiac myosin inhibitor that is similarly indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III oHCM to improve functional capacity and symptoms; it also carries a boxed warning for the risk of heart failure and is supplied as oral capsules with the dosage individualized based on clinical status and echocardiographic assessment of patient response
Boxed warning for risk of heart failure
Myqorzo is available from Cytokinetics through a REMS program

Dec. 23, 2025 – mitapivat (Aqvesme)

NDA approval; first oral medication for beta-thalassemia and first FDA-approved drug for alpha-thalassemia
Pyruvate kinase activator
Indicated for the treatment of anemia in adults with alpha- or beta-thalassemia
Tablets: 100 mg
Recommended dosage is taken orally twice daily with or without food
Approval was based on two multinational, randomized, double-blind, placebo-controlled clinical trials (ENERGIZE-T; n=258 transfusion-dependent thalassemia and ENERGIZE; n=194 non-transfusion-dependent thalassemia); in ENERGIZE-T, compared to placebo, a greater proportion of mitapivat patients achieved a transfusion reduction response (defined as ≥ 50% reduction in the number of red blood cell [RBC] units transfused with a reduction of at least two units of RBCs transfused in any consecutive 12-week period) (30% versus 13%, respectively; adjusted rate difference, 18%; 95% CI, 8 to 27; p=0.0003); in ENERGIZE, 42% of patients achieved a hemoglobin response compared with 2% of placebo patients from week 12 through week 24 (least-squares mean difference, 41%; 95% CI, 32 to 50, two-sided p<0.0001)
Other FDA-approved therapies for beta-thalassemia are indicated specifically for those who require RBC transfusions; these agents include luspatercept-aamt (Reblozyl) which is an erythroid maturation agent given SC, betibeglogene autotemcel (Zynteglo) which is an autologous HSC-based gene therapy given as a one-time, single-dose IV infusion (also indicated for pediatric patients) and exagamglogene autotemcel (Casgevy) which is an autologous genome edited HSC-based gene therapy given as a one-time, single-dose IV infusion
Boxed warning for hepatocellular injury
Aqvesme will be available from Agios in late January 2026 following implementation of the corresponding REMS program

Dec. 23, 2025 – narsoplimab-wuug (Yartemlea)

BLA approval; Breakthrough Therapy, Orphan Drug, Priority Review; first FDA-approved therapy for transplant-associated thrombotic microangiopathy
Mannan-binding lectin-associated serine protease 2 (MASP-2) inhibitor
Indicated for the treatment of adult and pediatric patients ≥ 2 years of age with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Solution for injection: 370 mg/2 mL in a single-dose vial
Recommended dosage is based on body weight once weekly given as an IV infusion over 30 minutes by an HCP; increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs/symptoms
Approval was based on a single-arm, open-label study (TA-TMA; n=28) that assessed TMA response, defined as clinical improvement in laboratory markers of TMA (platelets and lactate dehydrogenase) and either organ function improvement or freedom from transfusions; 61% of patients achieved a TMA response
TA-TMA is a serious complication of HSCT that can be life-threatening; the condition occurs from endothelial injury resulting in activation of the lectin pathway of complement; this leads to blood clot formation in small vessels which can result in organ (kidney, cardiovascular system, gastrointestinal tract) damage; TA-TMA has been predominantly managed with supportive care (e.g., modification of calcineurin inhibitor dosage, management of hypertension and acute kidney injury, treatment of infection)
Yartemlea is available from Omeros

Dec. 11, 2025 – trofinetide powder for oral solution (Daybue Stix)

505(b) NDA approval; new powder formulation of trofinetide that can be mixed with water-based liquids to form an oral solution; trofinetide is also FDA-approved as an oral solution in the strength of 200 mg/mL (Daybue) for the same indication as Daybue Stix; Orphan Drug
Analog of the amino-terminal tripeptide of insulin-like growth factor 1 (IGF-1)
Indicated for the treatment of Rett syndrome in adults and pediatric patients ≥ 2 years of age
Powder for oral solution: 5,000 mg, 6,000 mg or 8,000 mg of strawberry flavored powder per packet
Recommended dosage is administered orally twice daily (morning and evening) based on patient body weight; can be taken with or without food; can also be administered via gastrostomy (G) tube
Product will be available from Acadia on a limited basis beginning in the first quarter of 2026 with extended availability early in the second quarter of 2026; the current oral solution (Daybue) will continue to be available

Dec. 17, 2025 – amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)

BLA approval; Assessment Aid, Project Orbis; new SC formulation indicated for adults across all indications approved for the IV formulation of amivantamab-vmjw (Rybrevant)
Combination of amivantamab (a bispecific EGF receptor-directed and MET receptor-directed antibody) and hyaluronidase (an endoglycosidase)
Indicated (1) in combination with lazertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test, (2) in combination with carboplatin and pemetrexed for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor, (3) in combination with carboplatin and pemetrexed for the first-line treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test and (4) as a single agent for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy
Solution for injection: 1,600 mg amivantamab and 20,000 units hyaluronidase per 10 mL (160 mg and 2,000 units/mL) and 2,240 mg amivantamab and 28,000 units hyaluronidase per 14 mL (160 mg and 2,000 units/mL) in a single-dose vial
Recommended dosage is based on baseline body weight and is given SC in the abdomen over five minutes by an HCP; consult the product labeling for specific dosing regimens alone and in combination with other agents
Product will be available from Janssen with launch timeframe TBD

Dec. 19, 2025 – mosunetuzumab-axgb (Lunsumio Velo)

Supplemental BLA (sBLA) approval; Accelerated Approval; new SC formulation of mosunetuzumab-axgb (Lunsumio) IV
Bispecific CD20-directed CD3 T-cell engager
Indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy; Accelerated Approval based on response rate; therefore, continued approval for this use may require demonstration of benefit in confirmatory clinical trials
Solution for injection: 5 mg/0.5 mL and 45 mg/mL in single-dose vials; different dosage and route of administration instructions than IV Lunsumio (do not substitute for Lunsumio)
Recommended dosage is administered as a SC injection on days one, eight and 15 of cycle one followed by administration on day one of cycle two then every 21 days thereafter; administer for eight cycles unless patients experience unacceptable toxicity or disease progression (for patients who achieve a complete response, no further treatment beyond eight cycles is required); for patients who achieve a partial response or have stable disease after eight cycles, an additional nine cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression; administration only by a qualified HCP with appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS)
Boxed warning for CRS
Product will be available from Genentech with launch timeframe TBD

Oct. 29, 2025 – denosumab-desu (Jubereq)

BLA approval; the 120 mg/1.7 mL single-dose vial for SC use has received FDA approval as an interchangeable biosimilar to the same presentation of denosumab (Xgeva) 
Product will be available from Accord in 2026

Oct. 29, 2025 – denosumab-desu (Osvyrti)

BLA approval; the 60 mg/mL single-dose prefilled syringe for SC use has received FDA approval as an interchangeable biosimilar to the same presentation of denosumab (Prolia) 
Product will be available from Accord in 2026

Nov. 28, 2025 – eculizumab-aagh (Epysqli)

Samsung Bioepis; BLA approval; the 300 mg/30 mL single-dose vial for IV use of eculizumab-aagh (Epysqli) has received FDA approval as an interchangeable biosimilar to the same presentation of eculizumab (Soliris)
Previously, Epysqli was only approved as a biosimilar to Soliris; Epysqli is the second interchangeable biosimilar to Soliris

Nov. 28, 2025 – pegfilgrastim-unne (Armlupeg)

BLA approval; 6 mg/0.6 mL single-dose prefilled syringe for SC use has received FDA approval as biosimilar to the same presentation of pegfilgrastim (Neulasta) 
Product will be available from Lupin with launch timeframe TBD

Dec. 18, 2025 – ranibizumab-leyk (Nufymco)

BLA approval; 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) for intravitreal use in a single-dose glass vial has received FDA approval as interchangeable to 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL), respectively, in a single-dose prefilled syringe of ranibizumab (Lucentis) 
Product will be available from Formycon with launch timeframe TBD

Dec. 19, 2025 – denosumab-mobz (Boncresa)

BLA approval; 60 mg/mL single-dose prefilled syringe for SC use has received FDA approval as an interchangeable biosimilar to the same presentation of denosumab (Prolia) 
Product will be available from Amneal with launch timeframe TBD

Dec. 19, 2025 – denosumab-mobz (Oziltus)

BLA approval; 120 mg/1.7 mL single-dose vial for SC use has received FDA approval as an interchangeable biosimilar to the same presentation of denosumab (Xgeva) 
Product will be available from Amneal with launch timeframe TBD

Nov. 21, 2025 – enfortumab vedotin-ejfv (Padcev)

Astellas; nectin-4-directed antibody and microtubule inhibitor conjugate; Assessment Aid, Priority Review, Project Orbis
New indication: in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy
Administered as an IV injection by an HCP as a weight-based dose in the neoadjuvant setting on days one and eight of each 21-day cycle for three cycles or until disease progression that precludes curative- intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on days one and eight of each 21-day cycle for six cycles or until disease recurrence or unacceptable toxicity
Other indications are detailed in the product label

Nov. 21, 2025 – pembrolizumab (Keytruda)

Merck; programmed death receptor-1 (PD-1)-blocking antibody; Assessment Aid, Priority Review, Project Orbis
New indication: in combination with enfortumab vedotin-ejfv (Padcev), as neoadjuvant treatment, and then continued after cystectomy as adjuvant treatment for adults with MIBC who are ineligible for cisplatin-containing chemotherapy
Administered as an IV injection by an HCP; in the neoadjuvant setting, administer every three weeks for three doses in combination with Padcev or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity; in the adjuvant setting, administer every three weeks for 14 doses or every six weeks for seven doses in combination with Padcev or until disease recurrence or unacceptable toxicity
Other indications are detailed in the product label

Nov. 21, 2025 – pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)

Merck; combination of pembrolizumab, a PD-1-blocking antibody, and berahyaluronidase alfa, an endoglycosidase; Assessment Aid, Priority Review, Project Orbis
New indication: in combination with enfortumab vedotin-ejfv (Padcev), as neoadjuvant treatment, and then continued after cystectomy as adjuvant treatment for adults with MIBC who are ineligible for cisplatin-containing chemotherapy
Administered as a SC injection by an HCP in the thigh or abdomen only; in the neoadjuvant setting, administer every three weeks for three doses in combination with Padcev or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity; in the adjuvant setting, administer every three weeks for 14 doses or every six weeks for seven doses in combination with Padcev or until disease recurrence or unacceptable toxicity
Other indications are detailed in the product label

Nov. 24, 2025 – atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza)

Genentech; combination of atezolizumab, a programmed death-ligand 1 (PD-L1) blocking antibody, and hyaluronidase, an endoglycosidase
Expanded indication: pediatric patients (≥ 12 years of age who weigh ≥ 40 kg) for the treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS); previously only indicated for this use in adults
Administered as a SC injection by an HCP into the thigh over approximately seven minutes every three weeks; continue until disease progression or unacceptable toxicity
Other indications are detailed in the product label

Nov. 24, 2025 – nivolumab and hyaluronidase-nvhy (Opdivo Qvantig)

Bristol-Myers Squibb; combination of nivolumab, a PD-1-blocking antibody, and hyaluronidase, an endoglycosidase
Expanded indications: pediatric patients (≥ 12 years of age who weigh ≥ 30 kg) for the treatment of (1) unresectable or metastatic melanoma, (2) unresectable or metastatic melanoma following combination treatment with IV nivolumab (Opdivo) and ipilimumab (Yervoy), (3) adjuvant treatment of patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma, (4) unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following combination treatment with IV Opdivo and Yervoy and (5) MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan; previously only indicated for these uses in adults
Administered as a SC injection by an HCP only in the abdomen or thigh every two weeks or every four weeks depending on the dose; continue until disease progression or unacceptable toxicity for treatment of melanoma and MSI-H/dMMR metastatic CRC with progression on prior therapy; continue until disease recurrence or unacceptable toxicity for up to one year for adjuvant treatment of melanoma and until disease profession or unacceptable toxicity or up two years for MSI-H/dMMR CRC
Other indications are detailed in the product label

Nov. 25, 2025 – durvalumab (Imfinzi)

AstraZeneca; PD-L1 blocking antibody; Assessment Aid, Breakthrough Therapy, Orphan Drug, Priority Review, Project Orbis
New indication: in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent Imfinzi, for the treatment of adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)
Administered as an IV infusion by an HCP with dosing regimen dependent on body weight (≥ 30 kg: fixed dose; < 30 kg: weight-based dose); neoadjuvant dosing is in combination with FLOT chemotherapy every four weeks for up to two cycles prior to surgery; adjuvant dosing is in combination with FLOT chemotherapy every four weeks for up to two cycles and then as a single agent every four weeks for up to 10 cycles, for a total of up to 12 cycles after surgery
Other indications are detailed in the product label

Dec. 2, 2025 – pirtobrutinib (Jaypirca)

Eli Lilly; kinase inhibitor; Assessment Aid, Orphan Drug
New indication: adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor; previously, an Accelerated Approval for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
Administered orally once daily; swallowed whole with water; can be taken with or without food; should not be cut, crushed or chewed
Other indication: adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor

Dec. 5, 2025 – lisocabtagene maraleucel (Breyanzi)

Bristol-Myers Squibb; CD19-directed genetically modified autologous T cell immunotherapy; approval marks the first CAR T-cell therapy for adults with relapsed or refractory marginal zone lymphoma (MZL); Assessment Aid, Orphan Drug, Priority Review
New indication: for adults with relapsed or refractory MZL who have received at least two prior lines of systemic therapy
Administered as an IV infusion by an HCP of 90 to 110 × 10⁶ CAR-positive viable T cells; only for autologous use; patients require daily monitoring for at least seven days after the infusion for signs and symptoms of CRS and neurological toxicities
Other indications are detailed in the product label

Dec. 5, 2025 – omidubicel-onlv (Omisirge)

Gamida Cell; nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood; Orphan Drug, Priority Review
New indication: adults and pediatric patients ≥ 6 years of age with severe aplastic anemia (SAA) following reduced intensity conditioning
Administered as a one-time IV infusion by an HCP delivered in two separate bags consisting of (1) a cultured fraction (a minimum of 8 × 10⁸ total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 × 10⁷ CD34+ cells) and (2) a non-cultured fraction (a minimum of 4 × 10⁸ total viable cells with a minimum of 2.4 × 10⁷ CD3+ cells); thawing and diluting is required for both bags due to being cryopreserved; administration is under the supervision of a physician experienced in treatment of SAA in centers with expertise in HSCT
Other indication: adults and pediatric patients ≥ 12 years of age with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection

Dec. 11, 2025 – berotralstat (Orladeyo)

BioCryst; plasma kallikrein inhibitor; Orphan Drug, Priority Review; the FDA also approved a new oral pellet formulation in the strengths of 72 mg, 96 mg, 108 mg and 132 mg
Expanded indication: for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 years of age to < 12 years of age; previously only approved for this use in adults and pediatric patients ≥ 12 years of age
Recommended dosage for pediatric patients is given once daily as a weight-based dose using the oral pellets; administered by (1) pouring directly into mouth and swallowing immediately with non-acidic liquid or (2) sprinkling over one tablespoon (15 mL) of non-acidic soft food and consuming; a meal should be consumed just prior to or after administration

Dec. 11, 2025 – inebilizumab-cdon (Uplizna)

Amgen; CD19-directed cytolytic antibody
New indication: generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive
Administered as an IV infusion by an HCP with access to appropriate medical support to manage potential severe reactions (e.g., serious infusion reactions); following the initial dose, the second dose is given two weeks later; subsequent doses are given six months after the first infusion and are given every six months thereafter
Other indications are detailed in the product label

Dec. 12, 2025 – niraparib and abiraterone acetate (Akeega)

Janssen Biotech; combination of a poly (ADP-ribose) polymerase (PARP) inhibitor, niraparib, and a cytochrome P450 (CYP) 17 inhibitor, abiraterone acetate; patients should be selected for therapy based on an FDA-approved test
New indication: in combination with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC); previously indicated with prednisone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)
Recommended dosage is taken orally once daily in combination with prednisone; continued until disease progression or unacceptable toxicity

Dec. 15, 2025 – fam-trastuzumab deruxtecan-nxki (Enhertu)

Daiichi Sankyo; HER2-directed antibody and topoisomerase inhibitor conjugate; Assessment Aid, Breakthrough Therapy, Priority Review, Project Orbis, Real-Time Oncology Review (RTOR); the FDA also approved the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and HER2 Dual ISH DNA Probe Cocktail as companion diagnostic devices for selecting HER2-positive (HER2 IHC3+ or ISH+) breast cancer
New indication: in combination with pertuzumab (Perjeta) for first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test
Administered as a weight-based IV dose on cycle one, day one, followed by Perjeta; for subsequent cycles, the recommended Enhertu dose is weight-based, followed by Perjeta by IV infusion every three weeks; continue therapy until disease progression or unacceptable toxicity
Other indications are detailed in the product label

Dec. 17, 2025 – rucaparib (Rubraca)

Pharmaand GmbH; PARP inhibitor; Assessment Aid; patients should be selected for therapy based on use of an FDA-approved companion diagnostic
New indication: for adults with a deleterious BRCAm (germline and/or somatic)-associated mCRPC previously treated with an androgen receptor-directed therapy; previously, this indication was an Accelerated Approval and also required the patient to have been treated with a taxane-based chemotherapy
Recommended dosage is taken orally twice daily with or without food until disease progression or unacceptable toxicity
Other indication: for the maintenance treatment of adults with a deleterious BRCAm (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Dec. 19, 2025 – nerandomilast (Jascayd)

Boehringer Ingelheim; phosphodiesterase 4 (PDE4) inhibitor; Breakthrough Therapy, Orphan Drug, Priority Review
New indication: progressive pulmonary fibrosis in adults
Recommended dosage is taken orally twice daily with or without food; tablets should be swallowed whole or dispersed in water
Other indication: treatment of idiopathic pulmonary fibrosis in adults

Dec. 23, 2025 – adalimumab-aacf (Idacio)

Fresenius Kabi; tumor necrosis factor (TNF) blocker; Idacio is a biosimilar to adalimumab (Humira)
Expanded indications: pediatric patients ≥ 2 years of age for treatment of non-infectious intermediate, posterior and panuveitis and (2) treatment of moderate to severe hidradenitis suppurativa (HS) in adolescent patients ≥ 12 years of age; previously approved for these uses in adults
Recommended dosage for pediatric uveitis is based on body weight and is given every other week as a SC injection; recommended dosage for adolescent HS is based on body weight and requires an initial loading dose schedule; HS maintenance dosing is given every week or every other week; patients of appropriate age/caregivers can inject following proper training
Other indications are detailed in the product label

Dec. 23, 2025 – caplacizumab-yhdp (Cablivi)

Ablynx; von Willebrand factor (vWF)-directed antibody fragment
Expanded indication: to include adolescents ≥ 12 years of age for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy; previously only indicated for adults for this use
Recommended dosage is administered upon initiation of plasma exchange therapy; the first day of treatment requires a bolus IV injection administered by an HCP a minimum of 15 minutes before plasma exchange, this is followed by a SC injection after completion of plasma exchange on day one; subsequent treatment during daily plasma exchange consists of SC injections once daily after plasma exchange; following the plasma exchange period, a SC injection is given once daily for 30 days beyond the last plasma exchange; if following the initial treatment course signs of persistent underlying disease remain, treatment can be extended for a maximum of 28 days; in pediatric patients ≥ 12 years of age, administration must be by an HCP or an adult caregiver

Traditional

Dec. 10, 2025 – amoxicillin and clavulanate potassium (Augmentin XR)

Re-approval under the Commissioner’s National Priority Voucher (CNPV) pilot program; brand-name Augmentin XR has been unavailable in the U.S. since 2011; first approval through the CNPV review pathway
Combination of amoxicillin (penicillin-class antibacterial) and clavulanate potassium (beta-lactamase inhibitor)
Indicated for treatment of adults and pediatric patients weighing ≥ 40 kg who are able to swallow tablets with (1) community-acquired pneumonia or (2) acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing pathogens (e.g., Haemophilus influenzae, Moraxella catarrhalis, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus) and Streptococcus pneumoniae with reduced susceptibility to penicillin
Extended-release oral tablets: 1,000 mg/62.5 mg
Recommended dosage is taken orally twice daily every 12 hours for seven to 10 days depending on the type of infection; take tablets at the start of a meal that is not high in fat
Approval under the CNPV program enhances the U.S. drug supply chain through providing a domestic manufacturing facility and aids in addressing antibiotic shortages
Amoxicillin-clavulanate potassium is also available in various strengths as a powder for oral suspension, an oral tablet, a chewable tablet and a generic extended-release oral tablet in the 1,000 mg/62.5 mg strength
Augmentin XR will be available from USAntibiotics with timeframe TBD

Dec. 12, 2025 – etripamil (Cardamyst)

NDA approval
Calcium channel blocker
Indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults
Nasal spray: 70 mg etripamil per device
Recommended initial dosage is 70 mg administered as two nasal sprays, one spray into each nostril (each nasal spray device delivers two sprays; administration of two sprays together contains a total of 70 mg etripamil); if symptoms persist for 10 minutes after administration, a second dose of 70 mg administered as two nasal sprays, one spray into each nostril can be given (maximum dose of 140 mg in a 24-hour period); patients/caregivers are instructed to call their HCP or seek emergency medical help if symptoms do not improve within 20 minutes after a second dose; Cardamyst should be administered as soon as possible after PSVT symptom onset
Approval was based on a randomized, double-blind, placebo-controlled phase 3 study (RAPID; n=692) that evaluated the time for return to normal sinus rhythm (determined by continuously recorded electrocardiographic data) for at least 30 seconds within 30 minutes after the first dose, following self-administration of study drug for a perceived episode of PSVT; 64% of patients who self-administered etripamil returned to normal heart rhythms within 30 minutes compared with 31% of patients who self-administered placebo (hazard ratio, 2.62; 95% CI, 1.66 to 4.15; p<0.0001); the median time to return to normal rhythm was 17 minutes in the etripamil arm and 54 minutes in the placebo arm
Cardamyst provides a treatment option that can be self-administered outside of a health care setting (e.g., emergency department) for conversion of acute symptomatic episodes of PSVT to sinus rhythm; other FDA-approved therapies administered in a health care setting for conversion of patients include IV administration of the calcium channel blocker diltiazem and IV administration of the atrioventricular (AV) node blocker adenosine
Cardamyst is available from Milestone

Dec. 12, 2025 – lerodalcibep-liga (Lerochol)

BLA approval
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor
Indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH)
Solution for injection: 300 mg/1.2 mL in a single-dose prefilled syringe
Recommended dosage is given SC once monthly into the abdomen or thigh; a caregiver or HCP can inject into the upper arm; patients/caregivers can administer following proper training
Approval was based on three randomized, double-blind, placebo-controlled trials (n=2,017 adults); in trial 1 (primary hypercholesterolemia), the mean percentage change in LDL-C from baseline to week 52 was -55% with lerodalcibep-liga compared to placebo (p<0.0001); similarly, in trial 2 conducted in primary hypercholesterolemia patients, the percent change in LDL-C from baseline to week 52 was -50% with lerodalcibep-liga compared to placebo (p<0.0001); in trial 3 (LIBerate-HeFH; n=478) conducted in adults with HeFH, the percent change in LDL-C from baseline to week 24 was -59% with lerodalcibep-liga compared to placebo (p<0.0001)
Lerochol is the third PCSK9 inhibitor to receive FDA approval; alirocumab (Praluent) is similarly indicated but also has an additional indication for reduction in the risk of major adverse cardiovascular events (MACE) (e.g., coronary heart disease death, myocardial infarction, stroke, unstable angina requiring hospitalization) in adults at increased risk for these events; Praluent is also indicated for pediatric patients ≥ 8 years of age with HeFH as well as adults with homozygous familial hypocholesteremia (HoFH); evolocumab (Repatha) carries the same indication as Lerochol as well as the MACE reduction carried by Praluent; Repatha is also indicated for pediatric patients ≥ 10 years of age with HeFH as well as adult and pediatric patients ≥ 10 years of age with HoFH
Lerochol will be available from Lib in the spring of 2026

Dec. 12, 2025 – zoliflodacin (Nuzolvence)

NDA approval; Fast Track, Priority Review, Qualified Infectious Disease Product (QIDP)
Spiropyrimidinetrione bacterial type II topoisomerase inhibitor
Indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adult and pediatric patients ≥ 12 years of age weighing ≥ 35 kg; to reduce the development of drug-resistant bacteria and maintain its effectiveness, Nuzolvence should only be used to treat/prevent infections proven/strongly suspected to be caused by bacteria
Granules for oral suspension: 3 g unit-dose packets
Recommended dosage is one packet administered as a single dose orally; patients weighing 35 kg to < 50 kg should take on an empty stomach (one hour before or two hours after food); patients weighing ≥ 50 kg should administer with food
Approval was based on a multinational, randomized, controlled, open-label, non-inferiority, phase 3 trial (n=744 patients); based on microbiological cure rates at the test of cure visit in the microbiologic intention-to-treat population (patients who had N. gonorrhoeae isolated at baseline from the urethra/cervix and who were not infected with a strain that showed resistance to both ceftriaxone and azithromycin), the estimated difference between zoliflodacin (90.9%) and comparator (ceftriaxone 500 mg intramuscular [IM] plus azithromycin 1 g oral; 96.2%) was -5.3% (95% CI, -8.7 to -1.4) which met the prespecified non-inferiority criteria
The CDC’s Sexually Transmitted Infections Treatment Guidelines from 2021 recommend a single 500 mg IM dose of ceftriaxone for persons weighing < 150 kg (for persons weighing ≥ 150 kg, 1 g ceftriaxone) for uncomplicated gonococcal infection of the cervix, urethra or rectum among adults and adolescents; if the patient has a cephalosporin allergy, a single dose of gentamicin 240 mg IV plus 2 g oral azithromycin can be given, or if ceftriaxone is not available or feasible a single 800 mg oral dose of cefixime can be given
Nuzolvence will be available from Entasis in the second half of 2026

Dec. 30, 2025 – tradipitant (Nereus)

NDA approval; first new drug therapy for motion sickness in more than four decades
Substance P/neurokinin-1 (NK-1) receptor antagonist
Indicated for the prevention of vomiting induced by motion in adults
Capsules: 85 mg
Recommended dosage is a single oral dose of one or two capsules approximately 60 minutes before an event expected to cause vomiting induced by motion (maximum dosage in 24 hours is a single dose of 85 mg or 170 mg); the safety of use for the prevention of vomiting induced by motion in adults for > 90 doses has not been established; administer on an empty stomach, at least one hour prior to or two hours after a full meal
Approval was based on two randomized, double-blind, placebo-controlled studies (Motion Syros; n=365; Motion Serifos; n= 316) conducted in subjects taking a boat trip scheduled to last two to five hours; study drug was taken 60 minutes prior to the trip without food; the primary endpoint was the percentage of subjects with vomiting during the boat trip; at both doses studied (both FDA approved doses) tradipitant resulted in a significant reduction in the incidence of vomiting compared to placebo; for Motion Syros, the incidence of vomiting was 18% with the 170 mg dose and 20% with the 85 mg dose versus 44% with placebo (p<0.0001 for both dose comparisons versus placebo); in Motion Serifos, the incidence of vomiting was 10% with the 170 mg dose and 18% with the 85 mg dose compared to 38% with placebo (p≤0.0014)
Other FDA-approved therapies for motion sickness include antihistamines (e.g., dimenhydrinate, diphenhydramine, meclizine, promethazine) and the anticholinergic agent scopolamine (Transderm Scop)
Nereus will be available from Vanda in the coming months

Dec. 16, 2025 – semaglutide oral tablets (Wegovy)

505(b) NDA approval; approval marks the first oral glucagon-like peptide-1 (GLP-1) for weight loss in adults
GLP-1 receptor agonist
Indicated in combination with a reduced calorie diet and increased physical activity: (1) to reduce the risk of MACE (cardiovascular [CV] death, non-fatal myocardial infarction or non-fatal stroke) in adults with established CV disease and either obesity or overweight and (2) to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition
Limitation of use: concomitant use of semaglutide tablets or semaglutide injection with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended
Tablets: 1.5 mg, 4 mg, 9 mg and 25 mg
Recommended dosage is administered orally once daily on days one to 30 at the lowest tablet strength (1.5 mg), then the dosage should be increased to the next tablet strength (4 mg) taken daily on days 31 to 60, followed by the second highest tablet strength (9 mg) daily on days 61 to 90; the maintenance dosage is the highest tablet strength (25 mg) and is taken daily starting on day 91 and onward; tablets should be taken on an empty stomach in the morning with up to 4 oz of water and must be swallowed whole; patients should wait at least 30 minutes after taking to eat food, drink beverages or take other oral medications
Boxed warning for risk of thyroid C-cell tumors
Product is available from Novo Nordisk

Dec. 22, 2025 – sildenafil oral film (Vybrique)

505(b)(2) NDA approval; other oral formulations of sildenafil for erectile dysfunction are supplied as oral tablets (Viagra, generics)
Phosphodiesterase-5 (PDE5) inhibitor
Indicated for the treatment of erectile dysfunction (ED)
Oral film: 25 mg, 50 mg, 75 mg, 100 mg
Recommended dosage is administered orally with or without food, taken as needed, approximately one hour before sexual activity; however, can be taken anywhere from 30 minutes to four hours before sexual activity; maximum recommended dosing frequency is once per day; oral film should be placed directly onto the tongue, it will disintegrate and can then be swallowed with saliva without the need for water or other liquid
Product will be available from IBSA with timeframe TBD

Dec. 9, 2025 – imipenem, cilastatin and relebactam (Recarbrio)

Merck; combination of imipenem (a penem antibacterial), cilastatin (a renal dehydropeptidase inhibitor) and relebactam (a beta-lactamase inhibitor)
Expanded indication: to include pediatric patients (birth to <18 years of age) weighing ≥ 2 kg for treatment of the following infections caused by susceptible gram-negative microorganisms: complicated urinary tract infections (cUTI), including pyelonephritis in patients who have limited or no alternative treatment options; complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); previously only indicated for these uses in adults
Administered as an IV infusion with dosage for pediatric patients dependent on age and body weight

Dec. 11, 2025 – gepotidacin (Blujepa)

GlaxoSmithKline; triazaacenaphthylene bacterial type II topoisomerase inhibitor; Fast Track, Priority Review, Qualified Infectious Disease Product
New indication: uncomplicated urogenital gonorrhea in adult and pediatric patients ≥ 12 years of age weighing ≥ 45 kg who have limited or no alternative treatment options; approval of this indication is based on limited clinical safety data for this indication
Recommended dosage is four tablets taken orally, followed by a second dose of four tablets approximately 12 hours later; take after a meal to reduce the possibility of gastrointestinal intolerance
Other indication: uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients ≥ 12 years of age weighing ≥ 40 kg

Dec. 13, 2025 – flibanserin (Addyi)

Sprout; serotonin 5-HT1A receptor agonist and serotonin 5-HT2A receptor antagonist; Priority Review
Expanded indication: to include women < 65 years of age independent of reproductive status; previously indicated only for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to (1) a co-existing medical or psychiatric condition, (2) problems within the relationship and (3) effects of a medication or other drug substance
Administered orally once daily at bedtime

Dec. 18, 2025 – cariprazine (Vraylar)

Abbvie; atypical antipsychotic; FDA also approved two new capsule strengths (0.5 mg, 0.75 mg)
Expanded indications: pediatric patients 13 to 17 years of age for the treatment of schizophrenia and pediatric patients 10 to 17 years of age for the acute treatment of manic or mixed episodes associated with bipolar I disorder; previously only indicated for these uses in adults
Administered orally once daily with or without food; requires dose titration; as cariprazine and its active metabolites have long half-lives, dose changes will not be fully evidenced in plasma concentration for several weeks; monitor for adverse reactions and response for several weeks after initiation and dosage changes
Other indications are detailed in the product label

Dec. 19, 2025 – ferric maltol (Accrufer)

Shield; iron replacement product; first prescription oral medication for iron deficiency in pediatric patients ≥ 10 years of age
Expanded indication: pediatric patients ≥ 10 years of age for the treatment of iron deficiency; previously only indicated for this use in adults
Administered orally twice daily on an empty stomach one hour before or two hours after meals; capsules should be swallowed whole; duration of therapy is dependent upon iron deficiency severity (usually ≥ 12 weeks of treatment); continue treatment as long as needed to replenish body iron stores (until ferritin levels are within the normal range)

Dec. 19, 2025 – tirzepatide (Mounjaro)

Eli Lilly; glucose-dependent insulinotropic polypeptide (GIP) receptor and GLP-1 receptor agonist
Expanded indication: to include pediatric patients ≥ 10 years of age with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control; previously only indicated for this use in adults
Administered as a SC injection once weekly at any time of day, with or without meals; requires dose titration; patients/caregivers can inject following proper training

Dec. 22, 2025 – furosemide (Furoscix)

SC Pharmaceuticals; loop diuretic supplied in a single-dose prefilled cartridge copackaged with a single-use on-body infusor
Expanded indication: treatment of edema in pediatric patients weighing ≥ 43 kg with chronic heart failure or chronic kidney disease, including nephrotic syndrome; previously only indicated for this use in adults
Administered with the single-use, on-body infusor that is pre-programmed to deliver a loading dose over the first hour followed by the remainder of the divided dose over the subsequent four hours; replace with oral diuretics as soon as practical; not for chronic use; in pediatric patients, must be administered by an HCP or adult caregiver

First generic drug launches

Oct. 29, 2025 – dalbavancin hydrochloride (Dalvance)

Teva launched generic vials (500 mg) to Abbvie’s Dalvance; Fresenius Kabi launched its generic vials (500 mg) on Nov. 12, 2025
Lipoglycopeptide antibacterial; indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms
Recommended dosage is administered as a single dose based on patient age, creatinine clearance and body weight (for pediatric patients) by an HCP as an IV infusion
Annual sales for Dalvance in 2024 were $395 million

Nov. 14, 2025 – lomustine (Gleostine)

Carnegie launched generic capsules (10 mg, 40 mg, 100 mg) to Azurity’s Gleostine
Alkylating drug; indicated for the treatment of patients with (1) brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures and (2) Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy
Recommended dosage is based on body surface area (BSA) taken as a single oral dose every six weeks; do not repeat for at least six weeks
Annual sales for Gleostine capsules in 2024 were $18 million

Nov. 24, 2025 – ciprofloxacin hydrochloride and hydrocortisone (Cipro HC)

Cosette launched a generic otic suspension (0.2%/1%) to Sandoz’s Cipro HC
Antibacterial combined with an anti-inflammatory corticosteroid; indicated for the treatment of acute otitis externa in adult and pediatric patients ≥ 1 year of age due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus and Proteus mirabilis
Recommended dosage is three drops of the suspension instilled into the affected ear twice daily for seven days
Annual sales for Cipro HC in 2024 were $24 million

Nov. 26, 2025 – cladribine (Mavenclad)

Apotex launched a generic tablet (10 mg) to EMD Serono’s Mavenclad
Purine antimetabolite; indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease in adults; due to its safety profile, use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS
Recommended dosage is a weight-based dose given orally and divided into two treatment courses; each treatment course is divided into two treatment cycles; the second cycle of the first treatment course is administered 23 to 27 days after the last dose of first course/first cycle; the first cycle for the second treatment course is administered at least 43 weeks after the last dose of the first course/second cycle followed by the second cycle administered 23 to 27 days after the last dose of the second course/first cycle; following the administration of two treatment courses, do not administer additional cladribine treatment during the next two years
Annual sales for Mavenclad tablets in 2024 were $752 million

Dec. 8, 2025 – amphetamine (Adzenys XR-ODT)

Actavis launched generic extended-release orally disintegrating tablets (3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg) to Neos’ Adzenys XR-ODT
Central nervous system (CNS) stimulant; indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients ≥ 6 years of age
Recommended dosage is taken orally once daily in the morning
Annual sales for Adzenys XR-ODT tablets in 2024 were $184 million

Dec. 15, 2025 – perampanel (Fycompa)

MSN launched generic oral suspension (0.5 mg/mL) to Catalyst’s Fycompa
Non-competitive AMPA glutamate receptor antagonist; indicated for (1) treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy ≥ 4 years of age and 2) adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy ≥ 12 years of age
Recommended dosage is taken orally once daily at bedtime
Annual sales for Fycompa oral suspension in 2024 were $42 million

Dec. 16, 2025 – diazepam (Diastat)

Navinta launched generic gel/delivery system (10 mg, 20 mg) to Bausch’s Diastat
Benzodiazepine; indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (e.g., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy ≥ 2 years of age
Recommended dosage is individualized for maximum beneficial effect
Annual sales for Diastat in 2024 is TBD

Dec. 17, 2025 – prednisone (Rayos)

Dr. Reddy’s Laboratories launched generic delayed-release oral tablets (1 mg, 2 mg) to Horizon’s Rayos
Corticosteroid; indicated (1) as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation, (2) for the treatment of certain endocrine conditions and (3) for palliation of certain neoplastic conditions
Recommended dosage is individualized based on disease severity and patient response; administer orally once per day
Annual sales for Rayos tablets in 2024 were $38 million

5-HT 5-hydroxytryptamine 

AMPA alpha-amino-3-hydroxy-5-methyl-4-isooxazole-propionic acid

ASHP American Society of Health-System Pharmacists

BCL-2 B-cell lymphoma 2 

BRCA2 BReast CAncer gene 2

BTK Bruton tyrosine kinase

CAR chimeric antigen receptor

CD cluster of differentiation

CDC Centers for Disease Control and Prevention

EGF epidermal growth factor

EGFR epidermal growth factor receptor

FDA Food and Drug Administration

HER2 human epidermal growth factor receptor 2

IHC3+ immunohistochemistry 3+

ISH in situ hybridization

LDL-C low-density lipoprotein cholesterol

MET mesenchymal epithelial transition

NASH nonalcoholic steatohepatitis

REMS Risk Evaluation and Mitigation Strategy

U.S. United States

Editor-In-Chief: Maryam Tabatabai, PharmD

Executive Editor: Anna Schreck Bird, PharmD

Deputy Editors: Nicole Kjesbo, PharmD, BCPS; Olivia Pane, PharmD, CDCES

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care provider.
All brand names are property of their respective owners.

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