Loyola Law School professor Adam Zimmerman says a recent Supreme Court decision in an impossibility preemption case highlights splits among liberal an...
Maquet/Datascope recalls all Intra-Aortic Balloon Pumps (IABP) due to reports about its batteries failing to hold a charge.
FDA approves a Samsung Bioepis BLA for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbotts Humira.
Federal Register notice: FDA submits to OMB an information collection extension for Clinical Laboratory Improvement Amendments waivers.
FDA acting commissioner Ned Sharpless outlines key agency priorities that include supporting emerging technologies, investing in the agencys next gene...
Jubilant Cadista Pharmaceuticals recalls one lot of drospirenone and ethinyl estradiol tablets due to out-of-specification dissolution results.
The World Health Organization releases for comment a working document on quality management system requirements for national regulatory authority insp...
Five stakeholders express appreciation for an FDA draft guidance on considerations for developing therapeutic protein biosimilars and suggest ways the...