Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...

The FDA panel voted against Otsuka's PTSD drug combination with Zoloft, questioning its efficacy. Getinge surpassed profit ...

The FDA panel rejects Otsuka's PTSD drug combination. Humana's lawsuit challenging Medicare rating downgrades is dismissed. Spain reports an avian flu outbreak, causing global supply concerns.