FDA News

First Generic GLP-1 RA Approved for Weight Management in the US: Daily Dose

September 10, 2025

Your daily dose of the clinical news you may have missed.

FDA OKs Semaglutide 2.4 mg for Treatment of MASH Without Cirrhosis: Daily Dose

September 08, 2025

Your daily dose of the clinical news you may have missed.

FDA Approves Automated Insulin Delivery System for Adults With Type 2 Diabetes

September 03, 2025

FDA clears MiniMed 780G for integration with Abbott’s Instinct sensor and approves its use in insulin-requiring T2D, expanding automated insulin delivery options.

FDA Approves Brensocatib for Non–Cystic Fibrosis Bronchiectasis: Daily Dose

September 02, 2025

Your daily dose of the clinical news you may have missed.

FDA Approves Subcutaneous Leqembi Autoinjector for Maintenance Therapy in Early Alzheimer Disease

September 01, 2025

The FDA has cleared Eisai and Biogen’s Leqembi Iqlik, the first at-home subcutaneous autoinjector for maintenance therapy in patients with early Alzheimer disease.

Generic Liraglutide Approved, Marking First Generic GLP-1 RA Indicated Specifically for Weight Management in the US

August 29, 2025

Teva announced approval of the generic formulation of Saxenda, which could help expand access to the extremely popular class of antiobesity medications.

FDA Approves First New Treatment for Fibromyalgia in Over 15 Years: Daily Dose

August 29, 2025

Your daily dose of the clinical news you may have missed.

Semaglutide 2.4 mg Approved for Treatment of MASH Without Cirrhosis: Daily Dose

August 26, 2025

Your daily dose of the clinical news you may have missed.

First Oral Penem Antibiotic Now Available in the US for Uncomplicated UTIs

August 20, 2025

The first oral penem antibiotic, Orlynvah™, has launched in the US, offering a vital treatment option for women with resistant uncomplicated UTIs.

FluMist Intranasal Flu Vaccine Now Available for At-Home Delivery and Self-Administration

August 18, 2025

AstraZeneca launches FluMist Home, the first FDA-approved at-home flu vaccine service, allowing self- or caregiver administration of the intranasal influenza vaccine for the 2025–26 season.