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

The FDA has accepted the resubmission of the BLA of Ordspono for review in relapsed/refractory follicular lymphoma following previous systemic therapy.

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

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

Regeneron Pharmaceuticals is taking another ... the FDA cited the study’s progress as the reason for issuing a complete response letter (CRL), marking the first time the agency had used this ...

(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 ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission ...

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.

TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN ... 1), which addressed the only issue cited in the FDA's complete response letter from the previous submission. The BLA for odronextamab, a CD20xCD3 ...

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

The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for ...