Four senators sponsor bipartisan legislation to speed some interchangeable biologics to market.
A former employee at Eli Lilly files a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired in retaliation for ra...
CDER Office of Drug Security, Integrity, and Response director Leigh Verbois tells how the APEC toolkit will be updated to address changing conditions...
Bristol-Myers Squibb settles an HIV medication anti-competitive conduct suit for $10.8 million.
FDA says it is difficult to determine the overall benefit-risk profile of Bluebird bios eli-cel (elivaldogene autotemcel) gene therapy, indicated for ...
An FDA Advisory Committee votes unanimously (21 to 0) to recommend that the agency grant Novavax an emergency use authorization for its Covid-19 vacci...
CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein leaves FDA for an undisclosed private sector job.
FDA warns Nixa, MO-based Aire-Master of America about CGMP and other violations in its manufacturing of two hand sanitizers.