June 5, 2026
Clinical Updates
Afrezza® (insulin human) – Expanded indication
May 29, 2026 - MannKind announced the FDA approval of Afrezza (insulin human), to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus.
Clinical Updates
Imfinzi® (durvalumab) – New indication
May 28, 2026 - The FDA announced the approval of AstraZeneca’s Imfinzi (durvalumab), in combination with Bacillus Calmette-Guérin (BCG), for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).
Clinical Updates
Uptravi® (selexipag) – Expanded indication
May 23, 2026 - The FDA approved Johnson & Johnson’s Uptravi (selexipag) tablets, for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in pediatric patients aged two years and older.
Drug Approvals
Decnupaz™ (pivekimab sunirine-pvzy) – New drug approval
May 27, 2026 - AbbVie announced the FDA approval of Decnupaz (pivekimab sunirine-pvzy), for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Drug Approvals
Xocova® (ensitrelvir) – New drug approval
June 1, 2026 - Shionogi announced the FDA approval of Xocova (ensitrelvir), for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.
Drug Approvals
Zaynich™ (cefepime/zidebactam) – New drug approval
May 30, 2026 - Wockhardt announced the FDA approval of Zaynich (cefepime/zidebactam), for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa.
Drug Recalls - Availability
Insulet – Medical Device Correction of Omnipod® and Omnipod DASH® Pods
May 26, 2026 - Insulet announced a voluntary medical device correction of Omnipod 5 and Omnipod DASH Pods because specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended.
Drug Safety
COVID-19 vaccines – VRBPAC makes recommendations for new monovalent vaccine composition for 2026 - 2027
May 28, 2026 - The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted in favor (8-1, with one abstention) to recommend the 2026 – 2027 formula of COVID-19 vaccines in the U.S. to include a vaccine targeting the JN.1-lineage XFG variant (consistent with the monovalent strategy used in prior seasons).
New Generics
Janumet® (sitagliptin/metformin) – First-time generic
May 28, 2026 - Apotex and Sandoz launched AB-rated generic versions of Merck’s Janumet (sitagliptin/metformin) tablets.
New Generics
Januvia® (sitagliptin) – First-time generic
May 28, 2026 - Teva launched an AB-rated generic version of Merck’s Januvia (sitagliptin) tablets.