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

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...

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

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

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

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 ...

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

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

One of the major complaints levied against FDA by the current administration is that the approval process is too complicated, ...

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