On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...

Key Takeaways The U.S. Food and Drug Administration has updated its recall of a common thyroid medication to Class II The recall is due to subpotent active ingredients It affects roughly 160,630 ...

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.

The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time ...

The mind-expanding drugs may help heal many mental health conditions. But studies haven’t actually proved that yet.

SPRING HOUSE, PA — Johnson & Johnson has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA ...

The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of unreliable AI in high-stakes roles.

The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...