June 1 (Reuters) - Fulcrum Therapeutics said on Monday it would stop developing its experimental sickle-cell disease drug after the U.S. Food and Drug Administration raised cancer-risk concerns, which ...

For the roughly 1 to 2 percent of pancreatic-cancer patients whose tumors carry a specific genetic glitch called KRAS G12C, ...

Federal regulators have unveiled a pilot program for clinical trials that they say will reduce the time it takes to test drugs. The Food and Drug Administration program will feature real-time clinical ...

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...

On May 28, Fulcrum received meeting minutes in which the agency expressed heightened concerns about the benefit-risk profile of pociredir. ・The regulator’s observations left no viable regulatory path ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...

Donald Prater will lead the Human Foods Program and replace Kyle Diamantas, who is taking over as department commissioner.

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...