The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

The FDA has granted a priority review to dordaviprone for treating patients with recurrent H3K27M-mutant diffuse glioma, a ...

Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA ...

The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech ...

Regeneron and Sanofi said an FDA green light would make Dupixent the first targeted medicine in the U.S. for bullous pemphigoid, a debilitating and relapsing skin disease with underlying type 2 ...

The Food and Drug Administration (FDA) has approved Romvimza ™ (vimseltinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will ...

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

Nuvation has a best-in-class lung cancer drug that could be approved in the US in June. Read why I'm bullish on the stock ...

The U.K. is continuing to shape up regulation, adding reform of its accelerated drug approval process and its draft guidance on personalized mRNA cancer vaccines to new clinical trial regulations that ...

Ultragenyx (RARE) announced the FDA has accepted for review the Biologics License Application, or BLA, seeking accelerated approval for UX111 ...