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 ...

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

Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and ...

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

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

Eli Lilly's Alzheimer's drug, donanemab (Kisqali), just got a thumbs-up from the European Medicines Agency's (EMA) expert ...

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

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

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.

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