WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...

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 ...

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate ...

The sNDA filing acceptance initiates substantive FDA review for Ameluz PDT in sBCC, with a target action date of Sept. 28, 2026 and no identified filing deficiencies. Approval would establish the ...