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.
CDRH director Jeff Shuren says that life after Covid-19 at the Center could greatly benefit from more regulatory flexibility, which was critical in ge...
FDA approves a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older.
Bristol Myers Squibb withdraws a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion dependent beta t...
Federal Register notice: FDA withdraws its guidance entitled Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applicati...