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Released FDA Files Show Flawed Drug Approval Process

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained all-but-silent even when the agency rejects the advice of its advisory ...
JD Supra

FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA

The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...
RAPS

New FDA Manual Clarifies Refuse-to-File Criteria for Drug Submissions

When is a marketing application not even worth looking at? For the US Food and Drug Administration (FDA), it's a question with very real implications, both for drugs and medical devices being ...
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Outlook Therapeutics files FDA resolution request after rejection for vision loss drug

Outlook Therapeutics OTLK announced on Monday that it has submitted a formal dispute resolution request (FDRR) to the U.S. Food and Drug Administration (FDA) regarding its ONS-5010/LYTENAVA. The ...
Business Wire

FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe ...