The FDA will issue a decision on odronextamab’s accelerated approval in relapsed/refractory follicular lymphoma by 30 July ...

The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics ...

US biotech Regeneron Pharmaceuticals says that its investigational gene therapy DB-OTO showed clinically-meaningful hearing ...

Regeneron Pharmaceuticals announced that the ... The BLA acceptance follows a previous complete response letter from the FDA, indicating regulatory scrutiny and potential risks to timely approval.

Regeneron Pharmaceuticals (NASDAQ:REGN) is one of the leaders in the ophthalmic disease therapeutics market. In this article, dear Seeking Alpha readers, I present five factors that explain why I ...

(RTTNews) - Regeneron Pharmaceuticals ... In the previous submission, the FDA had issued a complete response letter based on the enrollment status of the confirmatory trials.

This was despite the upcoming patent expirations. It stated the following in its Q3 2024 investor letter: “We purchased Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), a biopharmaceutical ...

(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in ...