June 26, 2026
Clinical Updates
Capvaxive® (pneumococcal 21-valent conjugate vaccine) – Expanded indication
June 18, 2026 - Merck announced the FDA approval of Capvaxive (pneumococcal 21-valent conjugate vaccine), for active immunization 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 in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease.
Clinical Updates
Skyrizi® (risankizumab-rzaa) – Expanded indication, new strength
June 12, 2026 - The FDA approved AbbVie’s Skyrizi (risankizumab-rzaa), for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
Clinical Updates
Tecelra® (afamitresgene autoleucel) – Expanded indication, accelerated approval converted to traditional approval
June 17, 2026 - The FDA approved US WorldMeds’ Tecelra (afamitresgene autoleucel), for the treatment of adults and pediatric patients 12 years of age and older 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 FDA-approved or cleared companion diagnostic devices.
Drug Approvals
Utebzi (tebipenem pivoxil) – New drug approval
June 17, 2026 - GSK announced the FDA approval of Utebzi (tebipenem pivoxil), for the treatment of complicated urinary tract infections (cUTI), 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.
New Generics
Myrbetriq® Granules (mirabegron) – First-time generic
June 17, 2026 - Ascend launched an AB-rated generic version of Astellas’ Myrbetriq Granules (mirabegron) extended-release oral suspension.