Zachary Brennan

The FDA has once again rejected Replimune's oncolytic virus therapy to treat advanced melanoma.

The FDA is getting closer to announcing a director of the Center for Biologics Evaluation and Research, sources told Endpoints News, following the controversial tenure of outgoing leader Vinay Prasad.

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Former CDER director Richard Pazdur pointed to several issues with FDA Commissioner Marty Makary's priorities and highlighted the unprecedented political interference in the FDA's drug reviews in an interview with Endpoints News.

As the prices paid for priority review vouchers have crept up over the past year, companies now have to make difficult decisions on whether using the vouchers to speed up their own approvals makes financial sense.

HHS Secretary Robert F. Kennedy Jr. defended the FDA and Commissioner Marty Makary during a House hearing on Thursday morning, saying that Makary is under …

HHS Secretary Robert F. Kennedy Jr. told Congress on Tuesday that 'China is eating our lunch' on new drug approvals and clinical trial starts.

The law firm Covington & Burling, on behalf of an unnamed pharmaceutical company client, filed a citizen petition dated Monday with the FDA seeking to reform the rules around the FDA's release of information in the letters that may be competitively sensitive, and potentially open the agency up for a lawsuit.

Outlook Therapeutics said the agency has reversed course regarding its reformulated version of Avastin for the eye condition known as wet AMD.

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