The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder ...
REDWOOD CITY, Calif., March 03, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat ...
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process. FDA announced the publication of draft guidance on drug master files on October 18, ...
Zogenix’s only drug candidate is facing a long delay after the FDA refused to accept its marketing application, asking for toxicology data. The US regulator says it has two main problems with the ...
· Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities GSK plc ...
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