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

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

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

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

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

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

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

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

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

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

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