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...
FDA hits a milestone with the approval of Pfizers Abrilada (adalimumab - afzb), a biosimilar to AbbVies Humira, which is the 25th biosimilar product a...
FDA sends Nascent Biotech an untitled letter objecting to promotional content on the companys Web site about its investigational drug pritumumab.