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 ...

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

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

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

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

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

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

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

Top-Line Data from Dry Eye Chamber Trial and Field Trial Expected in Q2 2025 Pending Positive Results and Discussions with the FDA, New Drug Application Resubmission Expected Mid-Year 2025 Aldeyra ...

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 ...