FDA extends by 30 days the comment period on a request for information entitled AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program."...
A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Courts Loper Bright deci...
FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.
The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whether federal drug la...
Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path toward U.S. approval of ...
FDA investigators cite major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pharmaceuticals.
Dyne Therapeutics submits a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy therapy z-rostudirsen.
