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

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

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 ...

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

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on Thursday, in a push to increase transparency under Health Secretary Robert F ...

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

In its Complete Response letter, FDA asserts that the BEST clinical study, which serves as the pivotal Phase III trial for the application, does not adequately demonstrate efficacy of Gencaro in ...

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

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

Acadia Pharmaceuticals has received a complete response letter from the FDA stating that the administration cannot approve a supplemental new drug application for pimavanserin.The application ...

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.