RAPS

FDA Kicks off Reauthorization Process for PDUFA

The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug ...
RAPS

With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations

The Biotechnology Industry Organization (BIO), a trade group which represents biopharmaceutical companies, is launching a new tracking tool meant to assess how companies interact with the US Food and ...
Morningstar

Leqembi® Iqlik™ PDUFA date updated to August 24 in the U.S.

STOCKHOLM, May 8, 2026 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by ...

Inovio outlines cash runway into Q1 2027 as INO-3107 targets October 30, 2026 PDUFA date

Q1 2026 Management View "These are very busy times at Inovio as we remain focused on achieving our top priority, advancing our lead candidate, INO-3107 through the regulatory process and toward its ...