FDA releases its latest batch of Warning Letters that includes A.P. Deauville, Apothecus Pharmaceutical Corp., Carolina Liquid Chemistries, and Torren...
Reps. Cicilline and Nadler introduce legislation to strengthen FTC authority to win cases against drug companies that try to move patients to another ...
The Center for Science in the Public Interest says FDA and the Federal Trade Commission should take enforcement action against 27 companies that manuf...
The Federal Trade Commission says that Bristol-Myers Squibb and Celgene will divest Celgenes Otezla to Amgen to resolve antitrust concerns in the BMS ...
CDRH technical guidance specialist Jason Ryans explains how FDA will use the new safety and performance-based 510(k) pathway.
FDA accepts for review a Samsung Bioepis BLA for SB8, a biosimilar candidate referencing Genentechs Avastin (bevacizumab).
An FDA device safety update says more adverse event reports have been received about intra-aortic balloon pumps by Getinges Maquet/Datascope.
President Donald Trump pulls back administration plans to issue new rules on e-cigarettes/vaping to curb youth access, reportedly due to feared politi...