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 ...
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 ...

FDA set to pilot test real-time tracking of clinical trials

The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and ...
C&EN

March 13 Policy Watch: FDA streamlines its process for approving biosimilar drugs

The US Food and Drug Agency announced on March 9 new guidelines for testing biosimilar products, biologic drugs that are made by someone other than the inventor. Whereas a generic-drug manufacturer ...
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 ...