FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioanalytical method valid...
FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyrosine receptor kinas...
Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned during electrosurgery ...
FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.
The U.S. Supreme Court 6/13 unanimously rejects a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Dancos ...
FDA updates its advice on this falls Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S.
FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.
Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better understand the status of t...
