Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...
FDA takes down page warning of crank autism cures as RFK Jr. nominates people have promoted them - Robert F KennedyJr says ...
"Gene editing takes centre stage in FDA’s new rare disease approval pathway" was originally created and published by ...
The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
What to eat? GRAS status allows manufacturers to use approved ingredients in food without undergoing repeated evaluations.
Popular weight-loss drugs, including Ozempic, Wegovy, Trulicity and Mounjaro, produced by independent pharmacy labs, sickened ...
The FDA has announced what it calls movement on implementation of the Food Traceability Rule, but some food safety experts say the agency isn’t really moving the needle. In its announcement, the Food ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
By Ahmed Aboulenein WASHINGTON, Feb 23 (Reuters) - U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency's position and record on mRNA vaccines, days after it ...
PARSIPPANY, N.J. & TEL AVIV, Israel & PARIS, February 20, 2026--Regulatory News: Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell ...