FierceBiotech

FDA delays decision on Biohaven's rare disease drug filing, plans adcomm

Biohaven is giving investors whiplash. Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed an approval decision on its rare disease candidate troriluzole ...
RAPS

FDA Finalizes Guidance on Priority Review Process for Medical Devices

Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document, ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
Vietnam Investment Review on MSN

C Ray Therapeutics receives FDA acceptance for copper 64 file

CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been ...
Morningstar

Sesh Products US Inc.'s Nicotine Pouch Bundled PMTA Advances to FDA Substantive Scientific Review Phase

Application Covering 64 SKUs Clears FDA Filing Review, Poised to Enter the Final Regulatory Phase Prior to a Marketing Order Decision Sesh Products US, Inc. (Sesh) today announced that the U.S. Food ...