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

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

Replimune (REPL) announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, regarding the Biologics ...

FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in ...

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) is one of the 11 Best All-Time Low Stocks to Buy According to Analysts. On July ...

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...