FDA releases the FDA-483 with seven observations from an inspection at West Columbia, SC-based Nephron Sterile Compounding Center.
The CDER Office of Prescription Drug Promotion cautions Althera that a professional promotion for its cholesterol-lower drug Roszet contains false and...
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...