Articles related to FDA

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.

FDA priority review vouchers granted to three psychedelic developers and a recent executive order may accelerate regulatory timelines for psilocybin and related compounds, with clinical availability potentially within 12 months pending positive Phase 3 data.

The FDA approved a supplemental NDA adding randomized withdrawal trial data to the lumateperone label, supporting its role in long-term maintenance and relapse prevention in adults with schizophrenia.