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, ...

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

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

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

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

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

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

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

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.

A paper published in the British Medical Journal, authored by FDA staff, compares content from FDA's complete response letter for a rejected drug, with the subsequent press release by drug developers.