publications

Findings from the ATTAIN-MAINTAIN study — a double-blind, placebo-controlled Phase 3b trial — have been published in Nature Medicine. Participants previously treated with tirzepatide (n=205; Cohort 1) or semaglutide (n=171; Cohort 2) during the SURMOUNT-5 trial were randomized to once-daily, oral orforglipron (Foundayo; equivalent to 17.2 mg or maximum tolerated dose [MTD]) or placebo. At Week 52, model-based estimates (MBE) were used to determine the percentage of patients who maintained initial weight reduction. Among Cohort 1 participants who reached a body-weight plateau, treatment with orforglipron maintained an MBE of 74.7% of the initial weight reduction, compared with 49.2% with placebo. This corresponded to an estimated treatment difference of 25.5% (95% confidence interval [CI], 14.5–36.5; P<0.001; treatment-regimen estimand) at Week 52. Of the patients in Cohort 2 who reached a body-weight plateau, those who had treatment with orforglipron maintained an MBE of 79.3% of the initial weight reduction, compared with 37.6% of patients who were switched to placebo. This corresponded to an estimated treatment difference of 41.7% (95% CI, 24.4–59; P<0.001; treatment-regimen estimand) at Week 52. These study results support oral orforglipron as a potential option for minimization of weight changes following injectable glucagon-like peptide-1 (GLP-1) receptor agonist therapy. Study limitations include the 52-week duration and lack of an active comparator arm with continuation of an injectable GLP-1.

Results from the SURMOUNT-MAINTAIN study — a multicenter, double-blind, randomized, placebo-controlled Phase 3b trial — have been published in The Lancet. Following completion of the initial 60-week weight-loss phase with once-weekly subcutaneous (SC) tirzepatide (Zepbound) at the MTD (10 mg or 15 mg), adult participants meeting inclusion criteria (body mass index [BMI] of ≥30 kg/m² — or ≥27 kg/m² with at least one weight-related comorbidity — and a history of at least one unsuccessful dietary attempt) were randomized in a 3:3:2 ratio to one of three groups: continued tirzepatide at the maximum tolerated dose (n=140), continued tirzepatide with dose reduction to 5 mg (n=144) or discontinued tirzepatide with transition to placebo (n=94) for an additional 52 weeks. Starting at Week 84, participants were able to receive rescue tirzepatide if their weight regain exceeded 50%. At Week 112, the primary endpoint of the percentage change in body weight from baseline was evaluated. Enrolled participants had an average body weight of 113.8 kg, a BMI of 40.1 kg/m² and a hemoglobin A1C (HbA1c) of 5.64%. The primary endpoint was calculated based on the mean, model-based estimated percentage change in body weight from baseline to Week 112. The estimated percent change was -21.9% (95% CI, -23.5 to -20.3) for the tirzepatide MTD group and -16.6% (95% CI, -18 to -15.1) for the tirzepatide 5-mg group, compared with -9.9% (95% CI, -11.1 to -8.8) with placebo (P<0.0001 for all comparisons). Authors concluded that continuation of tirzepatide at the MTD supports sustained weight reduction and maintenance of associated health benefits. Dose de-escalation to 5 mg, rather than full discontinuation, may represent an alternative strategy; however, patient response to this approach appears variable.

The Food and Drug Administration (FDA) has issued a Safety Labeling Change Order requiring the addition of a boxed warning to the prescribing information for ADAMTS13, recombinant-krhn (Adzynma). This update is intended to address safety concerns related to the development of neutralizing antibodies to ADAMTS13, which have been associated with serious outcomes, including death. Adzynma is FDA-approved for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura.
Updates have been made to the Drugs Facts label for the over-the-counter (OTC) weight-loss drug orlistat (Alli) 60 mg capsules to highlight the risk of acute kidney injury. Consumers are advised to consult a healthcare professional (HCP) prior to use if they have a history of kidney disease or kidney stones, and to discontinue the drug if they experience symptoms such as back or groin pain, dysuria, hematuria, peripheral edema or decreased urine output. The revisions align with labeling across all FDA-approved orlistat products. Although rare, cases of acute kidney injury, hyperoxaluria, calcium oxalate nephrolithiasis or oxalate nephropathy have been reported in association with orlistat use.
The FDA’s Center for Drug Evaluation and Research (CDER) has accepted the first Letter of Intent (LOI) for an in silico drug development tool (DDT), marking the initial step in the three-stage DDT qualification pathway. The next phases include submission of a Qualification Plan and, finally, submission of a comprehensive qualification package. Once qualified, the sponsor will be permitted to incorporate the DDT into the drug development process. This particular DDT is an artificial intelligence (AI)-driven digital liver model designed to assess the risk of drug-induced liver injury (DILI) in small-molecule investigational drugs. It is intended to complement current preclinical data and support decision-making prior to the initiation of Phase 1 clinical studies.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended that the 2026–2027 coronavirus 2019 (COVID-19) vaccine formulation incorporate a JN.1-lineage XFG severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant. This lineage was selected for inclusion in the updated monovalent vaccine to better match currently circulating SARS-CoV-2 strains.
The FDA’s VRBPAC met in June to discuss and provide recommendations regarding the safety and efficacy of Moderna’s messenger ribonucleic acid (mRNA) influenza vaccine (mFlusiva, also known as mRNA-1010). The proposed indication under review is for the prevention of influenza disease caused by the specific influenza virus A and B subtype strains included in the vaccine, in adults 50 years of age and older. The advisory committee voted in favor of approval of mRNA-1010 for both adults 50–64 years of age and adults 65 years of age and older. Recommendations from VRBPAC are considered nonbinding; a decision from the FDA regarding approval is expected by Aug. 5, 2026.

The FDA has announced that Novo Nordisk will discontinue the manufacture of semaglutide (Rybelsus) tablets in the 3 mg, 7 mg and 14 mg strengths. These products have been replaced by semaglutide (Ozempic) tablets in 1.5 mg, 4 mg and 9 mg strengths.
The FDA has approved a New Drug Application (NDA) permitting OTC use of adapalene/benzoyl peroxide (Differin Epiduo Acne Gel) gel 0.1%/2.5% for the treatment of acne in patients 12 years of age and older.
The CDC is actively monitoring the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda, which is caused by the Bundibugyo virus. As of July 1, 2026, no cases linked to this outbreak have been identified in the United States, and the overall risk to the public remains low. As of early July, most reported cases are concentrated in the DRC, with 1,333 confirmed cases and 399 deaths.
Preliminary data from the CDC’s National Vital Statistics System indicate a 13.9% decrease in U.S. overdose deaths in 2025 compared with 2024. Based on data available as of May 3, 2026, an estimated 69,973 drug overdose deaths occurred during the 12-month period ending in December 2025. These figures are provisional and are updated monthly as further records are received.

The American Cancer Society released an updated guideline on colorectal cancer (CRC) screening. It reaffirms the recommendation that average-risk adults undergo screening from 45–75 years of age, provided they have a life expectancy exceeding 10 years. The update also highlights the role of newly approved molecular-based screening tests.
The American College of Obstetricians and Gynecologists (ACOG) has published its first 2026 maternal immunization schedule, offering evidence-based vaccine recommendations for pregnant, postpartum and lactating individuals, as well as their infants. This schedule has been endorsed by 13 additional medical and health organizations.
The American Academy of Pediatrics (AAP) has issued a policy statement addressing the prescribing of generic drugs and biosimilars for children and adolescents.
The United States Pharmacopeia (USP) has released its 2025 annual drug shortages report. While total drug shortages decreased for the second consecutive year, the average duration of a shortage now exceeds five years. Additionally, 170 drug products were discontinued in 2025, representing a 60% increase compared with 2024.
The Infectious Diseases Society of America (IDSA) has issued a 2025 update to its clinical practice guidelines on antiviral therapy for adults with mild-to-moderate COVID-19. The update includes nine evidence-based recommendations addressing the use of nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury) and molnupiravir (Lagevrio) in this patient population.
A multistep global consensus process describing the development of a new name for polycystic ovary syndrome (PCOS) has been published. The term “polyendocrine metabolic ovarian syndrome” was selected, emphasizing diagnostic accuracy over retention of the PCOS acronym or adoption of a more generic name.

Drug Approvals

Specialty

May 22, 2026 — bulevirtide-gmod (Hepcludex)

Biologics License Application (BLA) approval; Accelerated Approval, Breakthrough Therapy and Orphan Drug designations; first FDA-approved treatment for chronic hepatitis delta virus (HDV) infection
Sodium taurocholate cotransporting polypeptide (NTCP)-directed HDV-attachment inhibitor
Indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis; Accelerated Approval based on participants who achieved a decrease in HDV ribonucleic acid (RNA) and alanine aminotransferase (ALT) normalization; continued approval may require demonstration of benefit in a confirmatory clinical trial(s)
Lyophilized powder for reconstitution and injection: 8.5 mg in a single-dose vial
Recommended dosage administered once daily by SC injection; continue treatment if associated with a response (optimal treatment duration is unknown); manage underlying hepatitis B virus (HBV) infection as clinically appropriate in all patients; patients/caregivers can administer following proper training
Approval was based on a multicenter, randomized, open-label, parallel-arm Phase 3 trial (MYR301; n=100) enrolling patients with chronic HDV infection without cirrhosis or with compensated cirrhosis; patients were randomized to immediate treatment with bulevirtide-gmod 8.5 mg SC, once daily for 144 weeks, or to delayed treatment (48-week observational period, followed by bulevirtide-gmod 8.5 mg SC, once daily for 96 weeks); the primary endpoint was a combined response at Week 48 of an undetectable HDV RNA level, or a level that decreased by ≥2 log₁₀ international units (IU) per milliliter from baseline, and normalization of the ALT level; findings showed a primary endpoint response in 48% of patients in the immediate-treatment group compared with 2% in the delayed-treatment group (rate difference, 46%; 95% CI, 31%–61%; P<0.001)
Boxed warning for post-treatment severe acute exacerbation of HDV and HBV
Hepcludex is a first-in-class entry inhibitor for adults with chronic HDV infection, a serious and life-threatening liver disease that only occurs in individuals with HBV; HDV infection can cause rapid liver fibrosis, liver cancer and liver failure resulting in death; interferon products have been used off-label for some patients with HDV
Hepcludex is available from Gilead Sciences

May 27, 2026 — pivekimab sunirine-pvzy (Decnupaz)

BLA approval; Assessment Aid, Breakthrough Therapy, Orphan Drug and Priority Review designations
Cluster of differentiation (CD)123-directed antibody and alkylating agent conjugate
Indicated for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Lyophilized cake for reconstitution, dilution and injection: 2 mg in a single-dose vial
Recommended dosage is administered as an intravenous (IV) infusion over approximately 15–30 minutes by an HCP; administered as a weight-based dose, once every three weeks, until disease progression or unacceptable toxicity; to reduce risk of infusion-related reactions, administer premedications the day prior to and the day of the infusion
Approval was based on a multicenter, open-label, single-arm clinical trial (CADENZA) evaluating adults with treatment-naïve BPDCN (n=33) or relapsed or refractory BPDCN (n=51) who received 0.045 mg/kg of pivekimab sunirine once every three weeks; the primary endpoint was the rate of complete remission (CR) or clinical complete remission (CRc); in the treatment-naïve arm, 69.7% (95% CI, 51.3–84.4) achieved a CR/CRc with a median follow-up of 21.5 months and a median CR/CRc duration of 9.7 months, with 13 of these 33 patients (39.4%) being able to receive post-study treatment hematopoietic stem cell transplant (HSCT); in the relapsed or refractory group, 15.7% (95% CI, 7–28.6) achieved a CR/CRc with a median follow-up of 24.1 months and a median CR/CRc duration of 9.2 months, with six of these 51 patients (11.8%) being able to receive post-study treatment HSCT
Boxed warning for hepatotoxicity, including hepatic veno-occlusive disease (VOD)
According to the National Comprehensive Cancer Network (NCCN) acute myeloid leukemia guidelines, decisions regarding the diagnosis and management of BPDCN should involve multidisciplinary consultation at a high-volume center with use of appropriate interventions, and consideration should be given to referral to an academic institution; tagraxofusp-erzs (Elzonris) is a CD123-directed cytotoxin FDA-approved for the treatment of BPDCN in adults and pediatric patients ≥2 years of age; Elzonris is administered as a weight-based IV infusion over 15 minutes on Days 1–5 of a 21-day cycle; the first cycle requires inpatient administration; subsequent cycles can be administered inpatient or in an appropriate outpatient setting; Elzonris carries a boxed warning for capillary leak syndrome; Decnupaz is a CD123-directed antibody-drug conjugate that binds to CD123-expressing cells; following intracellular processing, Decnupaz releases a payload (FGN849, a cytotoxic molecule) resulting in DNA alkylation and DNA breaks, apoptosis and cell death
Decnupaz is available from AbbVie

June 2, 2026 — tiopronin (Tiocystin)

505(b)(2) NDA approval; tiopronin is also FDA-approved as a delayed-release oral tablet (Venxxiva), which carries the same indication as Tiocystin and is also taken orally (100 mg and 300 mg strengths), in three divided doses at the same times each day, without food; tiopronin (Thiola and Thiola EC) are also FDA-approved for a similar patient population, which includes pediatric patients ≥20 kg (also taken in three divided doses at the same times each day); Thiola EC can be taken with or without food, but a routine pattern should be maintained with regard to meals
Reducing and complexing thiol
Indicated — in combination with high fluid intake, alkali and diet modification — for the prevention of cystine stone formation in adults and pediatric patients ≥9 years of age with severe homozygous cystinuria, who are not responsive to these measures alone
Oral tablets: 100 mg and 200 mg
Recommended dosage for pediatric patients is weight based; adults receive a fixed dose; the total daily dose is administered in three divided doses at the same times each day, at least one hour before or two hours after meals; measure urinary cysteine one month after starting therapy and every three months thereafter
Tiocystin will be available from Casper Pharma; the launch timeframe is to be determined (TBD)

May 15, 2026 — golimumab-sldi (Immgolis Intri)

BLA approval; 50 mg/4 mL solution in a single-dose vial for IV use has received FDA approval as an interchangeable biosimilar to the same presentation of golimumab (Simponi Aria)
- Immgolis Intri is only approved for adults with moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate
- Simponi Aria is also approved for patients ≥2 years of age with psoriatic arthritis (PsA), adults with ankylosing spondylitis (AS) and pediatric patients ≥2 years of age with polyarticular juvenile idiopathic arthritis
Immgolis Intri will be available from Accord BioPharma; the launch timeframe is TBD

May 15, 2026 — golimumab-sldi (Immgolis)

BLA approval; 50 mg/0.5 mL and 100 mg/mL single-dose prefilled syringe for SC use has received FDA approval as an interchangeable biosimilar to the same presentations of golimumab (Simponi)
- Immgolis is indicated for adults with moderately to severely active ulcerative colitis (UC) and adults with moderately to severely active RA, in combination with methotrexate
- Simponi is also approved in certain adults with PsA and AS and in pediatric patients with UC weighing ≥15 kg
Immgolis will be available from Accord BioPharma; the launch timeframe is TBD

June 2, 2026 — ranibizumab-hkdz (Ranluspec)

BLA approval; 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) single-dose prefilled syringe and single-dose glass vials for intravitreal use has received FDA approval as an interchangeable biosimilar to the same presentations of ranibizumab (Lucentis)
- Ranluspec is approved for the same indications as reference drug Lucentis and is the only interchangeable biosimilar to Lucentis that is approved in both prefilled syringes and vials
Ranluspec will be available from Lupin Limited; the launch timeframe is TBD

May 15, 2026 — atezolizumab (Tecentriq) and atezolizumab/hyaluronidase-tqjs (Tecentriq Hybreza)

Genentech; programmed death-ligand 1 (PD-L1) blocking antibody; Assessment Aid and Priority Review designations; FDA also approved Signatera CDx as a companion diagnostic device to select patients with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) for adjuvant treatment with Tecentriq or Tecentriq Hybreza
New indication: adjuvant treatment for adults with MIBC after cystectomy who have ctDNA MRD, as determined by an FDA-authorized test
Tecentriq is administered via IV by an HCP every two, three or four weeks, for up to one year, unless there is disease recurrence or unacceptable toxicity
Tecentriq Hybreza is given SC by an HCP every three weeks, for up to one year, unless there is disease recurrence or unacceptable toxicity
Other indications are detailed in the product label

May 15, 2026 — fam-trastuzumab deruxtecan-nxki (Enhertu)

Daiichi Sankyo; human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate; Assessment Aid, Breakthrough Therapy (adjuvant indication), Priority Review (adjuvant indication) and Project Orbis designations; FDA also approved two companion diagnostic devices — the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual in situ hybridization (ISH) DNA Probe Cocktail — both for identification of HER2-positive immunohistochemistry (IHC) 3-positive or ISH-positive patients for treatment with Enhertu
New indications: (1) for neoadjuvant treatment of adults with HER2-positive (IHC 3-positive or ISH-positive) Stage II or III breast cancer, as determined by an FDA-authorized test, followed by a taxane, trastuzumab and pertuzumab (THP); and (2) for the adjuvant treatment of adults with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment
Administered for neoadjuvant treatment as a weight-based dose, given as an IV infusion by an HCP every three weeks for four cycles, followed by the THP regimen for four cycles
Administered for adjuvant treatment, also as a weight-based dose, given as an IV infusion by an HCP every three weeks for a maximum of 14 cycles, unless there is disease recurrence or unacceptable toxicity
Other indications are detailed in the product label

May 21, 2026 — tocilizumab-aazg (Tyenne)

Fresenius Kabi; interleukin-6 (IL-6) receptor antagonist
Expanded indication: treatment of COVID-19 in hospitalized pediatric patients ≥2 years of age who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); previously approved for this use in adults only
Administered as a 60-minute IV infusion by an HCP as a weight-based dose that is dependent on body weight (<30 kg or ≥30 kg); if signs/symptoms worsen or do not improve after the first dose, one additional infusion can be administered, at least eight hours after the initial infusion
Other indications are detailed in the product label

May 22, 2026 — datopotamab deruxtecan-dlnk (Datroway)

Daiichi Sankyo; trop-2-directed antibody and topoisomerase inhibitor conjugate; Assessment Aid, Priority Review and Project Orbis designations
New indication: for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy
Administered as a weight-based dose given by an HCP as an IV infusion once every three weeks (21-day cycle) until disease progression or unacceptable toxicity; patients should be monitored for infusion-related reactions in a setting where cardiopulmonary resuscitation medication and equipment are available (monitor for at least one hour for the first two cycles; if there are no infusion-related reactions observed, monitor patients for at least 30 minutes for all subsequent infusion cycles)
Other indications are detailed in the product label

May 22, 2026 — tocilizumab-bavi (Tofidence)

Organon; IL-6 receptor antagonist
Expanded indication: treatment of COVID-19 in hospitalized pediatric patients ≥2 years of age who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or ECMO; previously approved for this use in adults only
Administered for pediatric patients with COVID-19 as a 60-minute IV infusion by an HCP as a weight-based dose (<30kg or ≥30 kg); if signs/symptoms worsen or do not improve after the first dose, one additional infusion can be administered, at least eight hours after the initial infusion
New indication: treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients ≥2 years of age
Administered for the treatment of CRS as a 60-minute IV infusion by an HCP as a weight-based dose (<30 kg or ≥30 kg); can be administered alone or in combination with corticosteroids; if there is not clinical improvement following the first dose, up to three additional doses can be administered, with an interval between consecutive doses of at least eight hours
Other indications are detailed in the product label

May 23, 2026 — selexipag (Uptravi)

Actelion Pharmaceuticals; prostacyclin receptor agonist
Expanded indication (tablets only): pediatric patients ≥2 years of age for the treatment of pulmonary arterial hypertension (PAH; World Health Organization [WHO] Group I); Uptravi reduces N-terminal pro B-type natriuretic peptide (NT-proBNP) and is expected to delay disease progression and reduce the risk of hospitalization for PAH; previously only indicated for adults to delay disease progression and reduce the risk of hospitalization for PAH (WHO Group 1)
Administered orally, twice daily, based on the patient’s body weight, and can be taken with food to improve tolerability; at weekly intervals, titrate in increments equivalent to the starting dose (e.g., 100 mcg, 150 mcg or 200 mcg given orally, twice daily), up to the highest tolerated dose or to the maximum dose allowed based on the patient’s body weight; reassess additional dosage titration based on changes in body weight over time

May 28, 2026 — durvalumab (Imfinzi)

AstraZeneca; PD-L1-blocking antibody; Assessment Aid designation
New indication: in combination with Bacillus Calmette-Guérin (BCG), for the treatment of adults with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC)
Administered as an IV infusion by an HCP; administered every four weeks for 13 cycles, in combination with BCG induction and maintenance; treatment should continue until recurrence of high-risk disease, disease progression, unacceptable toxicity or a maximum of 13 cycles; if Imfinzi is given on the same day as BCG, infuse Imfinzi first, then administer BCG as an intravesical instillation
Other indications are detailed in the product label

June 5, 2026 — marstacimab-hncq (Hympavzi)

Pfizer; tissue factor pathway inhibitor (TFPI) antagonist; Breakthrough Therapy designation for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in pediatric patients 6 to <12 years of age with hemophilia B, with and without inhibitors; Priority Review designation for expanded uses; FDA also approved a new 75 mg/0.5 mL prefilled pen and 75 mg/0.5 mL prefilled syringe for the expanded population
Expanded indications: to include pediatric patients ≥6 years of age for routine prophylaxis to prevent or reduce the frequency of bleeding episodes with hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency), with or without factor VIII inhibitors or factor IX inhibitors, respectively; previously only indicated for patients ≥12 years of age without factor VIII inhibitors for hemophilia A or without factor IX inhibitors for hemophilia B
Administered as an SC injection with a loading dose, followed by maintenance dosing initiated one week after the loading dose and given by SC injection on the same day each week, at any time of day; can be administered by a patient (if ≥12 years of age) or a caregiver, following proper training

Traditional

May 15, 2026 — baxdrostat (Baxfendy)

NDA approval; Priority Review designation
Aldosterone synthase inhibitor
Indicated for the treatment of hypertension, in combination with other antihypertensive drugs, to lower blood pressure in adults who are not adequately controlled on other agents; lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
Oral tablets: 1 mg and 2 mg
Recommended dosage is taken orally, once daily, with or without food
Approval was based on data from a multinational, double-blind, randomized, placebo-controlled Phase 3 study (BaxHTN; n=796) evaluating patients with a seated systolic blood pressure (SBP) of 140 mm Hg–<170 mm Hg, while currently receiving stable treatment with two antihypertensive medications (uncontrolled hypertension) or three or more antihypertensive medications (resistant hypertension); patients were randomized 1:1:1 to receive baxdrostat 1 mg, baxdrostat 2 mg or placebo, once daily, for 12 weeks; the primary endpoint was the change from baseline to Week 12 in seated SBP; the change from baseline in the least-squares mean seated SBP was -14.5 mm Hg (95% CI, -16.5 to -12.5) for the 1 mg baxdrostat group, -15.7 mm Hg (95% CI, -17.6 to -13.7) for the 2 mg baxdrostat group and -5.8 mm Hg (95% CI, -7.9 to -3.8) for the placebo group (P<0.001 for both baxdrostat groups compared with placebo)
Baxfendy is a first-in-class aldosterone synthase inhibitor that has demonstrated superiority to placebo in patients with uncontrolled and resistant hypertension; in the pivotal clinical study, the average blood pressure at baseline was 149/87 mm Hg across study groups, and the majority of patients enrolled had resistant hypertension; nearly all patients enrolled were receiving background therapy with a diuretic, followed by an angiotensin converting enzyme inhibitor (ACE-I) or angiotensin II receptor blocker (ARB), a calcium-channel blocker and/or a beta-blocker; Baxfendy provides a new mechanism of action for patients with uncontrolled/resistant hypertension; its 30-hour half-life allows for once-daily dosing
Baxfendy is available from AstraZeneca

May 29, 2026 — cefepime/zidebactam (Zaynich)

NDA approval; Fast Track, Priority Review and Qualified Infectious Disease Product (QIDP) designations
Combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial
Indicated for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex and Pseudomonas aeruginosa; use only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
Powder for reconstitution and injection: 2 grams cefepime and 1 gram zidebactam in a single-dose vial
Recommended dosage is given every eight hours by an HCP via IV infusion over one hour, for 7–10 days, in adults with an estimated glomerular filtration rate (eGFR) ≥60 mL/minute
Approval was based on data from a multinational, randomized, double-blind Phase 3 noninferiority study (ENHANCE-1; n=530) evaluating hospitalized adults with cUTI or pyelonephritis, with and without bacteremia; patients were randomized 2:1 to receive cefepime/zidebactam (2 grams/1 gram) or 1 gram of meropenem, administered via IV, every eight hours, for 7–10 days; the primary endpoint was composite response defined as clinical cure (complete resolution of the baseline signs and symptoms of cUTI or pyelonephritis) and microbiological response (defined as the baseline qualifying pathogen[s] reduced to <10³ colony-forming units [CFUs]/mL in urine) at the test-of-cure visit 10 days after the end of treatment; the primary endpoint was achieved in 89% of patients in the cefepime/zidebactam arm compared with 68.4% of patients in the meropenem arm (difference, 20.6%; 95% CI, 12.3–29.5)
According to the 2025 Infectious Disease Society of America guideline update on cUTI, for patients without sepsis requiring an IV route of administration, preferred agents include third- or fourth-generation cephalosporins, piperacillin-tazobactam or fluoroquinolones; carbapenems are considered alternative agents — as are novel beta-lactams/beta lactamase inhibitors — cefiderocol, plazomicin or older aminoglycosides; the active ingredients in Zaynich act synergistically by binding multiple penicillin-binding proteins, resulting in bacterial death; this activity occurs even in the presence of beta-lactamases and other nonenzymatic cefepime resistance mechanisms (e.g., hyper-efflux, downregulation of outer membrane porin channels)
Zaynich will be available from Wockhardt; product availability is TBD

June 1, 2026 — ensitrelvir (Xocova)

NDA approval; first oral option for post-exposure prophylaxis of COVID-19
SARS-CoV-2 main protease (Mᵖʳᵒ), also referred to as 3CLᵖʳᵒ or nsp5 protease, inhibitor
Indicated for post-exposure prophylaxis of COVID-19 in adults and adolescents ≥12 years of age, following contact with an individual who has COVID-19
Oral tablet: 125 mg
Recommended dosage is taken as an oral loading dose on Day 1, followed by one tablet orally on Days 2–5, taken with or without food; Xocova should be initiated as soon as possible and within 72 hours following contact with an individual who has COVID-19
Approval was based on data from a double-blind, randomized, placebo-controlled Phase 3 study (SCORPIO-PEP) evaluating household contacts of a patient with COVID-19 (index patient); patients were randomized to receive either ensitrelvir (n=1,030) or placebo (n=1,011) within 72 hours after symptom onset in the index patient; the primary endpoint was COVID-19 (defined by a central, laboratory-confirmed positive reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay in the presence of at least one of 14 COVID-19 symptoms lasting ≥48 hours) by Day 10 in a household contact; the incidence of COVID-19 was significantly lower in the Xocova group compared with the placebo group (2.9% versus 9%; risk ratio, 0.33; 95% CI, 0.22–0.49; P<0.001)
Xocova provides the first and only oral post-exposure prophylaxis agent for COVID-19
Xocova is available from Shionogi

May 14, 2026 — beclomethasone dipropionate/formoterol fumarate/glycopyrrolate (Trimbow)

505(b)(2) NDA approval; formoterol fumarate and glycopyrrolate are also available in combination with the inhaled corticosteroid (ICS) budesonide under the brand name Breztri Aerosphere; Breztri Aerosphere is indicated for the maintenance treatment of asthma in adult and pediatric patients ≥12 years of age, as well as in adults for the maintenance treatment of chronic obstructive pulmonary disease (COPD)
Combination of an ICS (beclomethasone dipropionate), a long-acting beta₂-agonist (LABA; formoterol fumarate) and an anticholinergic (glycopyrrolate)
Indicated for the maintenance treatment of asthma in adult patients ≥18 years of age; not indicated for relief of acute bronchospasm
Inhalation aerosol: 86 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 86 mcg/formoterol fumarate 4.9 mcg/glycopyrrolate 10.6 mcg) per actuation and 172 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 172 mcg/formoterol fumarate 4.9 mcg/glycopyrrolate 10.6 mcg) per actuation
Recommended dosage is two inhalations twice daily
Trimbow will be available from Chiesi Farmaceutici S.p.A.; launch timeframe TBD

May 21, 2026 — linaclotide (Linzess)

AbbVie; guanylate cyclase-C agonist; remains only FDA-approved prescription therapy for pediatric functional constipation
Expanded indication: treatment of functional constipation in pediatric patients ≥2 years of age; previously indicated for functional constipation in pediatric patients ≥6 years of age
Administered orally, once daily, on an empty stomach, at least 30 minutes prior to a meal, at approximately the same time each day
Other indications are detailed in the product label

May 29, 2026 — insulin human (Afrezza)

MannKind Corporation; rapid-acting inhaled human insulin
Expanded indication: to improve glycemic control in pediatric patients ≥6 years of age with diabetes mellitus; previously only indicated for this use in adults; not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or who have recently stopped smoking
Administered via oral inhalation at the beginning of each meal using the Afrezza inhaler; adjust the mealtime Afrezza dosage based on the patient's metabolic needs, blood glucose monitoring results and glycemic-control goal; if glycemic control is not achieved with increased doses, consider discontinuation

First generic drug launches

May 28, 2026 — sitagliptin phosphate (Januvia)

Multiple manufacturers launched oral tablets (25 mg, 50 mg and 100 mg) generic to Merck’s Januvia
Dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM)
Recommended dosage is taken once daily
Annual sales for Januvia in 2025 were $3,224 million (M)

May 28, 2026 — sitagliptin phosphate/metformin HCl (Janumet)

Apotex and Sandoz launched oral tablets (50 mg/500 mg and 50 mg/1,000 mg) generic to Merck’s Janumet
Combination of sitagliptin, a DPP-4 inhibitor, and metformin HCl, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM
Recommended dosage is taken orally, twice daily, with meals
Annual sales for Janumet in 2025 were $667M

June 3, 2026 — tofacitinib citrate (Xeljanz XR)

Multiple manufacturers launched tofacitinib XR oral tablets (11 mg) generic to Pfizer’s Xeljanz XR
Zydus launched tofacitinib XR oral tablets (22 mg) generic to Pfizer’s Xeljanz XR
Janus kinase (JAK) inhibitor indicated for the treatment of adults who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers for the treatment of moderately to severely active RA, PsA, AS and UC
Recommended dosage is taken once daily
Annual sales for Xeljanz XR 11 mg tablets in 2025 were $2,275M
Annual sales for Xeljanz XR 22 mg tablets in 2025 were $30M

June 3, 2026 — tofacitinib citrate (Xeljanz)

Multiple manufacturers launched tofacitinib oral tablets (5 mg) generic to Pfizer’s Xeljanz
Apotex and Aurobindo launched tofacitinib oral tablets (10 mg) generic to Pfizer’s Xeljanz on June 4, 2026
JAK inhibitor indicated for the treatment of adults who have had an inadequate response or intolerance to one or more TNF blockers for the treatment of moderately to severely active RA, active PsA, active AS, or moderately to severely active UC, and pediatric patients ≥2 years of age who have had an inadequate response or intolerance to one or more TNF blockers and have active PsA or active polyarticular course juvenile idiopathic arthritis (pcJIA)
Recommended dosage is taken twice daily
Annual sales for Xeljanz tablets in 2025 were $1,071M

June 3, 2026 — tofacitinib citrate (Xeljanz)

Multiple manufacturers launched tofacitinib oral solution (1 mg/mL) generic to Pfizer’s Xeljanz
JAK inhibitor indicated for the treatment of patients ≥2 years of age with (1) active PsA, who have had an inadequate response or intolerance to one or more TNF blockers, and (2) active pcJIA who have had an inadequate response or intolerance to one or more TNF blockers
Recommended dosage is taken twice daily
Annual sales for Xeljanz oral solution in 2025 were $36M

June 4, 2026 — macitentan (Opsumit)

Aurobindo launched macitentan oral tablets (10 mg) generic to Actelion’s Opsumit
Endothelin receptor antagonist (ERA) indicated for the treatment of PAH (WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH
Recommended dosage is taken once daily
Annual sales for Opsumit in 2025 were $1,711M

June 11, 2026 — bosutinib monohydrate (Bosulif)

Alembic launched bosutinib oral tablets (100 mg and 500 mg) generic to Pfizer’s Bosulif
Kinase inhibitor indicated for the treatment of (1) adults with chronic-phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), resistant or intolerant to prior therapy; and (2) adults with accelerated, or blast phase Ph+ CML, with resistance or intolerance to prior therapy
Recommended dosage is taken orally, once daily, with food
Annual sales for Bosulif in 2025 were $755M

AAP The American Academy of Pediatrics

ACE-I angiotensin-converting enzyme inhibitor

ACOG American College of Obstetricians and Gynecologists

AI artificial intelligence

ALT alanine aminotransferase

ARB angiotensin II receptor blocker

AS ankylosing spondylitis

BCG Bacillus Calmette-Guérin

BLA Biologics License Application

BMI body mass index

BPDCN blastic plasmacytoid dendritic cell neoplasm

CAR chimeric antigen receptor

CD cluster of differentiation

CDC Centers for Disease Control and Prevention

CDER Center for Drug Evaluation and Research

CFU colony-forming unit

CI confidence interval

CML chronic myelogenous leukemia

COPD chronic obstructive pulmonary disease

COVID-19 coronavirus 2019

CR complete remission

CRc clinical complete remission

CRC colorectal cancer

CRS cytokine release syndrome

ctDNA MRD circulating tumor DNA molecular residual disease

cUTI complicated urinary tract infections

DDT drug development tool

DILI drug-induced liver injury

DNA deoxyribonucleic acid

DPP-4 dipeptidyl peptidase-4

DRC Democratic Republic of the Congo

ECMO extracorporeal membrane oxygenation

eGFR estimated glomerular filtration rate

ERA endothelin receptor antagonist

FDA Food and Drug Administration

GLP-1 glucagon-like peptide-1

HbA1c hemoglobin A1C

HBV hepatitis B virus

HCl hydrochloride

HCP healthcare professional

HDV hepatitis delta virus

HER2 human epidermal growth factor receptor 2

HSCT hematopoietic stem cell transplant

ICS inhaled corticosteroid

IDSA Infectious Diseases Society of America

IHC immunohistochemistry

IL-6 interleukin-6

ISH in situ hybridization

IU international units

IV intravenous

JAK Janus kinase

LABA long-acting beta₂-agonist

LOI Letter of Intent

M million

MBE model-based estimates

MIBC muscle invasive bladder cancer

mRNA messenger ribonucleic acid

MTD maximum tolerated dose

NCCN National Comprehensive Cancer Network

NDA New Drug Application

NMIBC non-muscle invasive bladder cancer

NTCP sodium taurocholate cotransporting polypeptide

NT-proBNP N-terminal pro B-type natriuretic peptide

OTC over the counter

PAH pulmonary arterial hypertension

pcJIA polyarticular course juvenile idiopathic arthritis

PCOS polycystic ovary syndrome

PD-1 programmed cell death protein 1

PD-L1 programmed death-ligand 1

Ph+ Philadelphia chromosome-positive

PsA psoriatic arthritis

QIDP Qualified Infectious Disease Product

RA rheumatoid arthritis

RNA ribonucleic acid

RT-PCR reverse transcriptase–polymerase chain reaction

SARS-CoV-2 severe acute respiratory syndrome coronavirus 2

SBP systolic blood pressure

SC subcutaneous

T2DM type 2 diabetes mellitus

TBD to be determined

TFPI tissue factor pathway inhibitor

TNBC triple-negative breast cancer

TNF tumor necrosis factor

UC ulcerative colitis

USP United States Pharmacopeia

VOD veno-occlusive disease

VRBPAC Vaccines and Related Biological Products Advisory Committee

WHO World Health Organization

XR extended-release

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 healthcare provider.
All brand names are property of their respective owners.

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