Articles related to FDA

The FDA has approved an OTC switch for adapalene/benzoyl peroxide gel (Differin Epiduo) for patients 12 and older, expanding adolescent access to a fixed-dose retinoid combination without a prescription or clinical visit.

The FDA approved inhaled insulin (Afrezza) for pediatric patients aged 6 and older with type 1 or type 2 diabetes, based on phase 3 trial data and long-term safety evidence from manufacturer-sponsored studies.

The FDA accepted asundexian’s secondary-stroke-prevention application for Priority Review, supported by phase 3 OCEANIC-STROKE results in noncardioembolic ischemic stroke.

Ipsen voluntarily withdrew tazemetostat in follicular lymphoma and epithelioid sarcoma after 18 of 318 SYMPHONY-1 participants developed hematologic second primary malignancies, including three deaths.

The FDA announced on April 30, 2026 it is considering removing GLP-1 receptor agonists from the 503B bulks list, with public comment open through the end of June 2026.

The FDA approved dextromethorphan-bupropion (Auvelity) for agitation associated with dementia due to Alzheimer’s disease, based on phase 3 trial data and a long-term randomized withdrawal study.