Trending Topics & Drug Approvals: July 2026
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The Food and Drug Administration (FDA) selected seven companies for the new FDA PreCheck Pilot Program. The program is intended to enhance drug supply chain resilience by supporting the expansion of U.S.-based manufacturing capacity. Applicants were required to propose a new domestic manufacturing facility that would address a supply gap or improve access to therapies for conditions with limited treatment options. Additionally, companies were required to commit to submission of a New Drug Application (NDA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA) or a supplement to one of these applications that requires a new manufacturing facility.
Following a comprehensive evaluation of newly available clinical findings and the totality of existing evidence, the FDA requested updates to the prescribing information for testosterone replacement therapy (TRT) products. Proposed labeling updates include: (1) removal of the limitation of use stating that the safety and effectiveness of TRT in men with age-related hypogonadism have not been established; (2) incorporation of updated information on risks related to prostate cancer; and (3) revision of warnings related to benign prostatic hyperplasia.
Determinations were signed ending the coronavirus disease 2019 (COVID-19) Emergency Use Authorization (EUA) declarations for drugs, biological products and medical devices. For drugs and biological products, the declarations will terminate 12 months after the signed determination. The advance notice period is intended to give manufacturers, healthcare professionals (HCPs) and health systems sufficient time to transition away from products authorized for use only under the COVID-19 EUA.
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 30, 2026, to review and provide recommendations regarding the BLA for vusolimogene oderparepvec. The proposed indication for this therapy is for the treatment of adults with advanced melanoma who have previously received an anti-programmed cell death protein 1 (PD-1)-containing regimen, in combination with nivolumab (Opdivo).
The FDA approved the transition of naloxone hydrochloride nasal spray, 4 mg (Rextovy from Amphastar Pharmaceuticals) from prescription only to over the counter (OTC) for the emergency treatment of opioid overdose. OTC availability of Rextovy is expected to improve access to the potentially lifesaving medication.
The FDA authorized marketing of the first OTC continuous glucose monitoring (CGM) system approved for use in children, the Stelo Glucose Biosensor System (Dexcom). The integrated CGM is approved for individuals 2 years of age and older who are not receiving insulin therapy. This CGM system was previously approved only for adults.
The Centers for Disease Control and Prevention (CDC) published provisional U.S. mortality data for 2025. Overall, the mortality rate was 4.6% lower than in 2024. The leading cause of death was heart disease (694,708 deaths), followed by cancer (622,832 deaths) and unintentional injuries (184,265 deaths).
The Department of Health and Human Services (HHS) launched an initiative aimed at enhancing U.S. clinical research and accelerating the development of new treatments: Operation TrialBlazer. Key objectives of the initiative include decreasing unnecessary delays in clinical research, expanding U.S. research capacity, and increasing participation in clinical trials to ensure that future medical innovations and therapeutic advances are developed within the United States.
The American College of Physicians (ACP) released a living clinical guideline for the outpatient management of overweight and obesity in nonpregnant adults. The guideline provides recommendations on pharmacologic therapy and lifestyle interventions for internal medicine physicians and other HCPs. Semaglutide and tirzepatide are suggested as first-line treatment options, in combination with lifestyle modifications, for weight management for eligible patients.
The American Heart Association (AHA) and the American College of Cardiology (ACC) jointly issued the inaugural clinical practice guideline on cardiovascular-kidney-metabolic (CKM) syndrome, providing recommendations on screening, prevention and management. The guideline examines key risk factors for CKM syndrome (e.g., overweight/obesity, pre-diabetes/T2DM, high blood pressure and abnormal lipids). Recommended management approaches include lifestyle modification, treatment with GLP-1 receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors and bariatric surgery.
The American Academy of Pediatrics (AAP) published a clinical report on iron deficiency and iron-deficiency anemia in infants, children and adolescents. The report updates the 2010 guidance and offers current recommendations on screening, prevention, diagnosis and treatment.
The American Academy of Orthopaedic Surgeons (AAOS) released an evidence-based clinical practice guideline for the management of ankle osteoarthritis. Recommendations are provided for multiple treatment modalities, ranging from physical therapy and intra-articular injections to pharmacologic and surgical management.
A clinical practice guideline on central precocious puberty has been published by the Endocrine Society. Central precocious puberty is characterized by the onset of secondary sexual characteristics before 8 years of age in girls and 9 years of age in boys and is due to premature activation of the hypothalamic-pituitary-gonadal (HPG) axis.
The International Society on Thrombosis and Haemostasis (ISTH) issued guidance on the management of women with type 2B von Willebrand disease (VWD) during pregnancy and postpartum. Type 2B is an uncommon variant representing about 5% of patients with VWD.
Drug Approvals
Specialty
June 26, 2026 — veligrotug-vvze (Lumvoa)
BLA approval; Breakthrough Therapy and Priority Review designations; first FDA-approved therapy with labeling data for both active and chronic thyroid eye disease (TED)
Insulin-like growth factor-1 receptor inhibitor
Indicated for the treatment of TED regardless of TED activity or duration
Solution for injection: 500 mg/10 mL (50 mg/mL) in a single-dose vial
Recommended dosage is a weight-based intravenous (IV) infusion administered over 30–45 minutes by an HCP every three weeks for a total of five infusions
Approval was based on data from two randomized, double-masked, placebo-controlled, Phase 3 studies: THRIVE (n=113, active TED) and THRIVE-2 (n=188, chronic TED); in both studies, the primary endpoint of proptosis responder rate (PRR), defined as the proportion of patients with a ≥2 mm reduction in proptosis from baseline in the study eye without a corresponding ≥2 mm increase in the fellow eye, was evaluated at Week 15; in THRIVE, the PRR was 70% in the veligrotug study arm compared with 5% in the placebo arm at Week 15 (treatment difference, 65%; 95% CI, 52–78; P<0.001); in THRIVE-2, the PRR was 57% for the veligrotug group and 8% for the placebo group at Week 15 (treatment difference, 49%; 95% CI, 38–60; P<0.01)
Teprotumumab-trbw (Tepezza) is also an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of TED; Tepezza is also administered as a weight-based IV infusion administered every three weeks by an HCP over 60–90 minutes and is given for a total of eight infusions; Lumvoa and Tepezza carry the same warnings/precautions for infusion reactions, inflammatory bowel disease, hyperglycemia and hearing impairment, including hearing loss
Lumvoa is available from Viridian
June 30, 2026 — allogeneic regulatory T cell (Treg) immunotherapy with hematopoietic stem and progenitor cells (HSPC) and T cells-vldq (Tregzi; formerly known as Orca-T)
BLA approval; Assessment Aid, Orphan Drug, Priority Review and Regenerative Medicine Advanced Therapy (RMAT) designations; first regulatory T cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Allogeneic regulatory T cell-based immunotherapy with HSPC and T cells (donor-derived cellular immunotherapy)
Indicated for use in matched donor hematopoietic stem cell transplantation (HSCT) with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGVHD)-free survival, in the treatment of adults with hematological malignancies
Cell suspension for IV infusion comprised of three components that require sequential administration: purified HSPCs, Tregs and conventional T (Tcon) cells, all derived from peripheral blood of an 8/8 human leukocyte antigen (HLA)-matched related or unrelated donor; supplied in four separate infusion bags (HSPCs, Tregs, Tcons and Tcon diluent) labeled for the patient
Recommended dosage for each component is expressed in viable cells/kg, with the HSPC administered once on Day 0, the Tregs administered immediately after the HSPCs once on Day 0, and the Tcons administered once on Day +2 to +3 (after the start of the HSPC infusion on Day 0); an appropriate myeloablative preparative regimen should be administered prior to infusion of Tregzi, and diphenhydramine and/or acetaminophen should be administered approximately 40 minutes prior to the HSPC and Tcon infusions, based on institutional guidance (corticosteroids are strongly discouraged for premedication)
Approval was based on data from the multicenter, open-label, randomized, controlled PRECISION-T clinical trial (n=187) that enrolled adults with acute leukemias (acute lymphoblastic leukemia [ALL], acute myelogenous leukemia [AML] or mixed phenotype/undifferentiated) and myelodysplastic syndrome; patients were randomized to either Tregzi with tacrolimus or a conventional allograft (standard stem cell transplant) with tacrolimus and methotrexate (Tac/MTX); the primary endpoint was cGVHD-free survival (defined as the time from transplant to either death from any cause or the onset of moderate-to-severe cGVHD, within two years after Day 0); 14 events occurred in the Orca-T arm compared with 44 in the Tac/MTX arm, equating to a hazard ratio of 0.26 (multivariate Cox regression model; 95% CI, 0.14–0.47; P<0.001); at one year, the primary endpoint was met by 78% of patients in the Orca-T arm compared with 38.4% in the standard transplant arm; furthermore, the cumulative incidence of cGVHD was 12.6% with Orca-T compared to 44% with Tac/MTX (P<0.001)
Tregzi provides a novel therapeutic approach for allo-HSCT patients with high-risk blood cancers that demonstrated superior cGVHD-free survival to standard transplant
Tregzi will be available from Orca Bio; launch timeframe is to be determined (TBD)
July 7, 2026 — atacicept-vymj (Trutakna)
BLA approval; Accelerated Approval, Breakthrough Therapy and Priority Review designations; first FDA-approved B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) inhibitor for immunoglobulin A nephropathy (IgAN)
B-lymphocyte stimulator (BLyS)-specific (also known as BAFF) inhibitor and APRIL blocker
Indicated to reduce proteinuria in adults with primary IgAN at risk for disease progression; Accelerated Approval is based on a reduction in proteinuria; continued approval for this use may require demonstration of benefit in confirmatory clinical trial(s)
Solution for injection: 150 mg/mL in a single-dose, pre-filled autoinjector
Recommended dosage is administered by subcutaneous (SC) injection once weekly; patients and caregivers can administer following proper training
Approval was based on data from an ongoing, multicenter, randomized, double-blind, placebo-controlled, Phase 3 study (ORIGIN 3; n=203 prespecified interim analysis) that enrolled adults with biopsy-proven IgAN; the primary endpoint was the percent change from baseline in the 24-hour urinary protein-to-creatinine ratio (UPCR) at Week 36; the reduction from baseline in UPCR was 45.7% in the atacicept arm compared with 6.8% in the placebo arm (geometric mean difference, 41.8%; 95% CI, 28.9–52.3; P<0.001)
Sibeprenlimab-szsi (Voyxact) is also an APRIL blocker and is also approved under Accelerated Approval to reduce proteinuria in adults with primary IgAN at risk for disease progression; it is given as an SC injection once every four weeks by a patient or caregiver; the oral complement factor B inhibitor iptacopan (Fabhalta) is also approved under Accelerated Approval for reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a UPCR ≥1.5 g/g and is only available through a Risk Evaluation and Mitigation Strategies (REMS) program; the oral delayed-release corticosteroid budesonide (Tarpeyo) is indicated to reduce the loss of kidney function in adults with primary IgAN who are at risk for disease progression; sparsentan (Filspari) is an oral endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary IgAN who are at risk for disease progression and is only available through a REMS program; atrasentan (Vanrafia) is an oral endothelin receptor antagonist approved under Accelerated Approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a UPCR ≥1.5 g/g
Trutakna is available from Vera Therapeutics
May 29, 2026 — nilotinib orally disintegrating tablet (ODT; Cavhanza)
505(b)(2) NDA approval; Orphan Drug designation; new ODT formulation designed with improved solubility and dissolution allowing for concurrent use with acid-reducing agents (e.g., proton pump inhibitors [PPIs] and/or histamine 2 (H₂) antagonists) without regard to timing; nilotinib is also available as a capsule (Tasigna) that requires separation from H₂ antagonists and cannot be taken with PPIs, and as a tablet (Danziten) that does not carry the mealtime restrictions required with Tasigna
Kinase inhibitor
Indicated for the treatment of (1) adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and (2) adults with CP and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib
ODT: 60 mg and 80 mg; Cavhanza may have different strengths and dosages than other nilotinib products and may not be substitutable with other nilotinib products on a milligram-to-milligram basis
Recommended dosage is taken orally twice daily at approximately 12-hour intervals, with or without food; place ODT on top of the tongue, allow it to disintegrate then swallow with saliva (can also be chewed before swallowing or swallowed intact with water); dose is dependent on indication for use; use the dosage conversion table when switching between Cavhanza and Tasigna
Boxed warning for QT interval prolongation and sudden death
Cavhanza is available from Cycle Pharmaceuticals
None
June 12, 2026 — belzutifan (Welireg)
Merck Sharp & Dohme; hypoxia-inducible factor 2 alpha inhibitor; Assessment Aid and Priority Review designations; review conducted under Project Orbis
New indication: adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)
Administered orally once daily, with or without food
Other indications are detailed in the product label
June 12, 2026 — capivasertib (Truqap)
AstraZeneca Pharmaceuticals; kinase inhibitor; Assessment Aid used for review; FDA also approved a companion diagnostic device — the VENTANA PTEN (SP218) RxDx Assay — for identification of patients with PTEN-deficient prostate cancer
New indication: for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test, in combination with abiraterone and prednisone
Administered orally twice daily, with or without food, for four days, followed by three days off; continue treatment until disease progression or unacceptable toxicity; mAPMN/S prostate cancer patients should receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy
Other indication: the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy in combination with fulvestrant
June 12, 2026 — pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex)
Merck Sharp & Dohme; pembrolizumab is a PD-1-blocking antibody and berahyaluronidase alfa is an endoglycosidase; Assessment Aid and Priority Review designations; review conducted under Project Orbis
New indication: adjuvant treatment of adults with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, in combination with belzutifan (Welireg)
Keytruda is administered via IV infusion by an HCP every three or six weeks for up to one year, unless there is disease progression or unacceptable toxicity
Keytruda Qlex is given as an SC injection by an HCP every three or six weeks for up to one year, unless there is disease progression or unacceptable toxicity
Other indications are detailed in the product label
June 12, 2026 — risankizumab-rzaa (Skyrizi)
AbbVie; interleukin-23 antagonist; FDA also approved a new 55 mg/0.37 mL prefilled syringe in conjunction with the expanded patient age range
Expanded indication: for use in pediatric patients ≥6 years of age with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; previously approved for this use in adults
Administered as an SC injection with initial doses at Week 0 and Week 4, followed by maintenance dosing every 12 weeks thereafter; dose is based on patient body weight (<40 kg or ≥40 kg); can be administered by a patient or a caregiver following proper training (for patients ≥10 years of age: by or under the supervision of an adult; for patients 6 to <10 years of age: by an adult)
Other indications are detailed in the product label
June 12, 2026 — teplizumab-mzwv (Tzield)
Sanofi; cluster of differentiation (CD)3-directed antibody; Accelerated Approval
New indication: to delay the decline in endogenous insulin production in pediatric patients 8–17 years of age with recently diagnosed Stage 3 type 1 diabetes mellitus (T1DM); Accelerated Approval is based on evidence of reduced C-peptide decline; continued approval may require demonstration of clinical benefit in confirmatory trial(s)
Administered as an IV infusion by an HCP over a minimum of 30 minutes, once daily, for 12 consecutive days for each treatment course, for a total of two treatment courses; initiated as soon as possible following Stage 3 T1DM diagnosis but no later than eight weeks from diagnosis; dosing is based on body-surface area (BSA) and is titrated from Day 1 to Day 3, then continued through Day 12; the second 12-day treatment course is administered six months after the first treatment course; if the second course is delayed, administer the second treatment course within 6–12 months following the first treatment course
Other indication: delay the onset of Stage 3 T1DM in adult and pediatric patients ≥1 year of age with Stage 2 T1DM
June 17, 2026 — afamitresgene autoleucel (Tecelra)
US WorldMeds; melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy; expanded indication for pediatric patients and conversion from an Accelerated Approval to a traditional approval for the treatment of adults
Expanded indication: to include pediatric patients ≥12 years of age with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by an FDA-approved or cleared companion diagnostic device
Administered as an IV infusion of MAGE-A4 T cell receptor (TCR)-positive T cells; a lymphodepleting regimen of cyclophosphamide and fludarabine is required prior to the autologous infusion; premedication with acetaminophen and a histamine 1 (H1) antihistamine is required
June 24, 2026 — olezarsen (Tryngolza)
Ionis Pharmaceuticals; apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide (ASO); Breakthrough Therapy and Priority Review designations; FDA also approved a new 50 mg/0.8 mL single-dose autoinjector to correspond with the new use
New indication: as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (TG ≥500 mg/dL)
Administered as a once-monthly SC injection in the newly approved 50 mg strength; for patients who tolerate the 50 mg dosage and require additional TG reduction, the dosage can be increased to an 80 mg SC injection once monthly; patients/caregivers can administer following proper training
Other indication: as an adjunct to diet to reduce TG in adults with familial chylomicronemia syndrome (FCS)
June 24, 2026 — palbociclib (Ibrance)
Pfizer; kinase inhibitor; Assessment Aid used for review of the new indication; Breakthrough Therapy designation
New indication (capsules and tablets): in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment
Administered orally, once daily, for 21 days, followed by seven days off treatment; capsules are taken with food; tablets are taken with or without food
Other indications are detailed in the product label
June 24, 2026 — pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex)
Merck Sharp & Dohme; pembrolizumab is a PD-1-blocking antibody and berahyaluronidase alfa is an endoglycosidase; Assessment Aid and Project Orbis were used for the review of these new indications
New indication: in combination with sacituzumab govitecan-hziy (Trodelvy) for the first-line treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death-ligand 1 (PD-L1; Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test
Keytruda is administered via IV infusion by an HCP every three weeks or every six weeks, for up to two years, unless there is disease progression or unacceptable toxicity
Keytruda Qlex is given as an SC injection by an HCP every three weeks or every six weeks, for up to two years, unless there is disease progression or unacceptable toxicity
Other indications are detailed in the product label
June 24, 2026 — sacituzumab govitecan-hziy (Trodelvy)
Gilead Sciences; trophoblast cell surface antigen 2 (TROP-2)-directed antibody and topoisomerase inhibitor conjugate; Assessment Aid and Project Orbis were used for the review of these new indications
New indication: as a single agent for the first-line treatment of adult patients with unresectable, locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
New indication: in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the first-line treatment of adult patients with unresectable, locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test
Administered as a weight-based dose via IV infusion by an HCP on Day 1 and Day 8 of 21-day cycles; continue until disease progression or unacceptable toxicity; before each dose, premedicate to prevent infusion reactions and chemotherapy-induced nausea and vomiting (CINV); patients should be monitored during the infusion and for at least 30 minutes after completion
Other indications are detailed in the product label
June 26, 2026 — risankizumab-rzaa (Skyrizi)
AbbVie; interleukin-23 antagonist
Expanded indication: for active psoriatic arthritis (PsA) to include pediatric patients ≥6 years of age; previously, only approved for active PsA in adults
Administered as an SC injection, with initial doses at Week 0 and Week 4, followed by maintenance dosing every 12 weeks thereafter; dose is based on patient body weight (<40 kg or ≥40 kg); can be administered by a patient or a caregiver, following proper training (for patients ≥10 years of age: by or under the supervision of an adult; for patients 6 to <10 years of age: by an adult); can be administered alone or in combination with nonbiological disease-modifying antirheumatic drugs (DMARDs)
Other indications are detailed in the product label
June 29, 2026 — eculizumab-aagh (Epysqli)
Teva Pharmaceuticals and Samsung Bioepis; complement inhibitor; interchangeable biosimilar to eculizumab (Soliris)
New indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
Administered as an IV infusion by an HCP over 35 minutes weekly for the first four weeks, followed by a fifth dose one week later, then every two weeks thereafter
Other indications are detailed in the product label
June 29, 2026 — eculizumab-aeeb (Bkemv)
Amgen; complement inhibitor; interchangeable biosimilar to eculizumab (Soliris)
New indication: treatment of NMOSD in adults who are anti-AQP4 antibody positive
Administered as an IV infusion by an HCP over 35 minutes weekly for the first four weeks, followed by a fifth dose one week later, then every two weeks thereafter
Other indications are detailed in the product label
July 1, 2026 — exagamglogene autotemcel (Casgevy)
Vertex Pharmaceuticals; autologous genome edited hematopoietic stem cell-based gene therapy; Commissioner's National Priority Voucher (CNPV) pilot program; Fast Track, Orphan Drug and RMAT designations; approval marks the first gene therapy approved for patients ≥2 years of age with sickle cell disease (SCD)
Expanded indications: for patients ≥2 years of age with either SCD with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β-thalassemia (TDT); Casgevy was previously approved for treatment of patients ≥12 years of age with SCD with recurrent VOCs or TDT
Administered as an IV infusion by an HCP; recommended dosage is based on body weight dosed as CD34+ cells/kg; hematopoietic stem cell (HSC) mobilization is required, followed by apheresis to obtain CD34+ cells for Casgevy manufacturing; full myeloablative conditioning required between 48 hours and seven days before the Casgevy infusion
July 2, 2026 — von Willebrand factor/coagulation factor VIII complex, Human (Wilate)
Octapharma USA; von Willebrand factor (VWF) and coagulation factor VIII (FVIII)
Expanded indication: routine prophylaxis to reduce the frequency of bleeding episodes in VWD to include pediatric patients <6 years of age; previously approved for this use in patients ≥6 years of age
Administered as an IV infusion; dosage is based on patient’s age (<6 years or ≥6 years) and is dosed in international units (IU) per kg of body weight given two or three times per week; caregivers can administer following training by an HCP or hemophilia center
Other indications are detailed in the product label
Traditional
June 17, 2026 — tebipenem pivoxil (Utebzi)
NDA approval; Fast Track, Priority Review and Qualified Infectious Disease Product designations; first oral carbapenem antibiotic
Carbapenem antibacterial drug
Indicated for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca and Enterococcus faecalis in adult patients who have limited or no alternative oral treatment options; Utebzi should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria
Oral tablets: 300 mg
Recommended dosage is taken orally, every six hours for 7–10 days in patients with an estimated glomerular filtration rate (eGFR) between 60 and 150 mL/minute; do not take beyond the recommended treatment duration
Approval was based on data from a randomized, double-blind, double-dummy, noninferiority trial (PIVOT-PO; n=1,690) that compared tebipenem pivoxil 600 mg orally every six hours to imipenem-cilastatin 500 mg given intravenously every six hours for 7–10 days in hospitalized adults with cUTI or pyelonephritis; the primary endpoint was evaluated in the microbiological intention-to-treat (micro-ITT) population (n=929) that included all patients with Enterobacterales pathogens isolated from urine (≥10⁵ colony forming units [CFUs]/mL, or concurrently in blood culture at baseline) and was a composite of clinical cure and microbiologic response at the test-of-cure (TOC) visit at Day 17 +/- 2 days; tebipenem pivoxil was found to be noninferior to imipenem-cilastatin based on composite response rates (58.5% versus 60.2%; adjusted treatment difference, -1.3%; 95% CI, -7.5%–4.8%)
According to the 2025 Infectious Diseases Society of America (IDSA) guideline update on cUTI, for patients without sepsis requiring an oral route of administration, preferred agents include fluoroquinolones (ciprofloxacin, levofloxacin) or trimethoprim-sulfamethoxazole; amoxicillin-clavulanate or oral cephalosporins are considered alternatives; for patients without sepsis requiring an IV route of administration, preferred agents include third- or fourth-generation cephalosporins, piperacillin-tazobactam or fluoroquinolones; carbapenems (imipenem-cilastatin, doripenem, meropenem, ertapenem) are considered alternative agents — as are novel beta-lactams/beta lactamase inhibitors — cefiderocol, plazomicin or older aminoglycosides (gentamicin, amikacin, tobramycin); Utebzi provides an oral carbapenem option for adults with cUTI with a susceptible microorganism and limited or no alternative oral treatment options
Utebzi will be available from GlaxoSmithKline; launch is expected by the end of 2026
June 12, 2026 — potassium chloride oral solution (Pokonza)
505(b)(2) NDA approval; potassium chloride oral solution is also available in 10% (1.3 mEq potassium per mL) and 20% (2.6 mEq potassium per mL) strengths, as well as other formulations (extended-release tablet, extended-release capsule, solution for injection, powder for oral solution)
Potassium supplement
Indicated for the treatment and prophylaxis of hypokalemia, with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient
Oral solution: 5%; 10 mEq/15 mL potassium per mL
Recommended dosage is dependent on indication (treatment of hypokalemia, maintenance/prophylaxis), patient age (pediatric birth to 16 years of age or adult) and serum potassium level; doses are taken orally in divided doses for treatment, or once or twice daily for hypokalemia maintenance/prophylaxis
Pokonza will be available from Carwin Pharmaceutical Associates; launch timeframe is TBD
June 17, 2026 — pneumococcal 21-valent conjugate vaccine (Capvaxive)
Merck Sharp & Dohme; vaccine for active immunization; first pneumococcal conjugate vaccine (PCV) indicated specifically for use in this expanded patient population
Expanded indication: to include children and adolescents 2–17 years of age who are at increased risk for pneumococcal disease, for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B; previously indicated for this use in adults only
Administered as a single intramuscular (IM) dose by an HCP
Other indication: active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals ≥18 years of age (Accelerated Approval)
June 18, 2026 — dasiglucagon (Zegalogue)
Novo Nordisk; antihypoglycemic agent
Expanded indication: treatment of severe hypoglycemia in pediatric patients with diabetes who weigh ≥20 kg; previously indicated for this use in adult and pediatric patients with diabetes ≥6 years of age
Administered as an SC injection into the lower abdomen, buttocks, thigh or outer upper arm as soon as possible when severe hypoglycemia is recognized; patients and their caregivers should be instructed on the signs and symptoms of severe hypoglycemia; as severe hypoglycemia requires others to assist, the patient should inform those around them about Zegalogue and the corresponding instructions for administering; emergency assistance should be contacted immediately after administering the dose; if no response after 15 minutes, an additional dose can be administered while waiting for emergency assistance; once the patient has responded to treatment, oral carbohydrates should be given to restore liver glycogen and prevent hypoglycemia recurrence
June 29, 2026 — roflumilast cream, 0.3% (Zoryve)
Arcutis Biotherapeutics; phosphodiesterase-4 inhibitor; with this expanded indication, Zoryve cream, 0.3% is the first once daily, nonsteroidal therapy for plaque psoriasis in this younger age group
Expanded indication: to include pediatric patients ≥2 years of age for the topical treatment of plaque psoriasis, including intertriginous areas; previously approved for this use in adult and pediatric patients ≥6 years of age
Apply the topical 0.3% cream once daily to affected areas
Other indication: 0.15% and 0.05% cream formulations are indicated for the topical treatment of mild-to-moderate atopic dermatitis in patients ≥6 years of age and 2–5 years of age, respectively
First generic drug launches
June 17, 2026 — azilsartan medoxomil (Edarbi)
Lupin Pharmaceuticals launched oral tablets (40 mg and 80 mg) generic to Azurity Pharmaceuticals’ Edarbi
Angiotensin II receptor blocker indicated for the treatment of hypertension in adults to lower blood pressure; azilsartan medoxomil tablets can be used either alone or in combination with other antihypertensive agents
Recommended dosage is taken once daily, with or without food
Annual sales for Edarbi in 2025 are not available
July 1, 2026 — ferric carboxymaltose (Injectafer)
Mylan launched a solution for injection (100 mg/2 mL, 750 mg/15 mL and 1,000 mg/20 mL) generic to American Regent’s Injectafer
Iron-replacement product indicated for (1) the treatment of iron deficiency anemia (IDA) in select patients and (2) iron deficiency in adults with heart failure and New York Heart Association class II/III to improve exercise capacity
Recommended dosage is administered by an HCP via IV in 1–2 doses
Annual sales for Injectafer in 2025 are not available
AAP American Academy of Pediatrics
ACC American College of Cardiology
ACP American College of Physicians
AHA American Heart Association
AKT1 v-akt murine thymoma viral oncogene homolog 1
ALL acute lymphoblastic leukemia
allo-HSCT allogeneic hematopoietic stem cell transplantation
AML acute myelogenous leukemia
ANDA Abbreviated New Drug Application
AP accelerated phase
apoC-III apolipoprotein C-III
APRIL a proliferation-inducing ligand
AQP4 aquaporin-4
ASO antisense oligonucleotide
BAFF B-cell activating factor
BLA Biologics License Application
BLyS B-lymphocyte stimulator
BSA body surface area
ccRCC renal cell carcinoma with a clear cell component
CD cluster of differentiation
CDC Centers for Disease Control and Prevention
CFU colony-forming unit
CGM continuous glucose monitor(ing)
cGVHD chronic graft-versus-host disease
CI confidence interval
CINV chemotherapy-induced nausea and vomiting
CKM cardiovascular-kidney-metabolic
CML chronic myeloid leukemia
CNPV Commissioner's National Priority Voucher
COVID-19 coronavirus disease 2019
CP chronic phase
CPS combined positive score
cUTI complicated urinary tract infection
DMARD disease-modifying antirheumatic drug
eGFR estimated glomerular filtration rate
EUA Emergency Use Authorization
FCS familial chylomicronemia syndrome
FDA Food and Drug Administration
FVIII coagulation factor VIII
GLP-1 glucagon-like peptide-1
GnRH gonadotropin-releasing hormone
GVHD graft-versus-host disease
H₁ histamine 1
H₂ histamine 2
HCP healthcare professional
HER2 human epidermal growth factor receptor 2
HHS Department of Health and Human Services
HLA human leukocyte antigen
HPG hypothalamic-pituitary-gonadal axis
HR hormone receptor
HSC hematopoietic stem cell
HSCT hematopoietic stem cell transplantation
HSPC hematopoietic stem and progenitor cells
IDA iron deficiency anemia
IDSA Infectious Diseases Society of America
IgAN immunoglobulin A nephropathy
IM intramuscular
ISTH International Society on Thrombosis and Haemostasis
IU international units
IV intravenous
LGA large for gestational age
LMP last menstrual period
MAGE-A4 melanoma-associated antigen A4
mAPMN/S metastatic androgen pathway modulation-naïve or -sensitive
MCM major congenital malformation
mEq milliequivalent
micro-ITT microbiological intention-to-treat
MTX methotrexate
NDA New Drug Application
NIH National Institutes of Health
NMOSD neuromyelitis optica spectrum disorder
NYHA New York Heart Association
ODT orally disintegrating tablet
OTC over the counter
PCV pneumococcal conjugate vaccine
PD-1 programmed cell death protein 1
PD-L1 programmed death-ligand 1
Ph+ Philadelphia-chromosome positive
PIK3CA phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha
PPIs proton pump inhibitors
PRR proptosis responder rate
PsA psoriatic arthritis
PTEN phosphatase and TENsin homolog deleted on chromosome 10
REMS Risk Evaluation and Mitigation Strategies
RMAT Regenerative Medicine Advanced Therapy
RR risk ratio
SC subcutaneous
SCD sickle cell disease
SGA small for gestational age
SGLT2 sodium-glucose cotransporter 2
T1DM type 1 diabetes mellitus
T2DM type 2 diabetes mellitus
Tac/MTX tacrolimus and methotrexate
TBD to be determined
Tcon conventional T
TCR T cell receptor
TDT transfusion-dependent β-thalassemia
TED thyroid eye disease
TG triglycerides
TNBC triple-negative breast cancer
TOC test of cure
Treg regulatory T cell
TROP-2 trophoblast cell surface antigen 2
TRT testosterone replacement therapy
UPCR urinary protein-to-creatinine
VOCs vaso-occlusive crises
VWD von Willebrand disease
VWF von Willebrand factor
Editor-in-Chief: Maryam Tabatabai, PharmD
Executive Editor: Anna Schreck Bird, PharmD
Deputy Editors: Nicole Kjesbo, PharmD, BCPS; Olivia Pane, PharmD, CDCES
All brand names are property of their respective owners.
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