The CDC is reporting influenza-like illness (ILI) for the week ending March 15, 2025 (week 11). Seasonal influenza activity remains increased across the U.S. but has decreased for five consecutive...

Jan. 26, 2026 – folic acid oral solution (Quiofic) 505(b)(2) NDA approval; other formulations of folic acid include the following: oral capsule, oral tablet, solution for injection and an OTC oral...

PUBLICATIONS FDA Decisions Expected: January 2026 Your monthly synopsis of new drugs expected to hit the market All brand names are property of their respective owners. References SERENA-6 trial:...

Managed Healthcare Executive: Prior authorization using integrated medical claims data helps diabetes patients get medications faster, with two-thirds processed automatically by July 2025 in this...

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...

From next-gen CFTR modulators to gene therapy and real-world drug impact, cystic fibrosis care is constantly evolving. Maryam Tabatabai, PharmD, of Prime Therapeutics, explains how innovative...

New biosimilars Feb. 26, 2026 – zongertinib (Hernexeos) Boehringer Ingelheim; kinase inhibitor; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Commissioner's National Priority Voucher...

Prime Therapeutics Report shares more about single-treatment gene therapies and proper management