Morning Overview on MSN
The government just greenlit a daraxonrasib expanded-access program for pancreatic-cancer patients with the KRAS G12C mutation — opening the new targe…
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 ...
Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
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 ...
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 ...
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.
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