FDA warns Ponce, Puerto Rico-based Prime Labs about significant CGMP regulation violations in its production of finished drugs.
Leiters Health recalls 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpotency.
Federal Register notice: FDA issues a priority review voucher (pediatric disease product) to Vertex Pharmaceuticals for gaining approval of Casgevy (e...
FDA approves Bausch + Lombs Teneo Excimer Laser Platform for LASIK vision correction surgery for myopia and myopic astigmatism.
FDA approves a Medtronic PMA for its Percept RC Deep Brain Stimulation system.
CDER first-cycle drug approvals last year shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a just-released approvals repo...
FDA endorses vaporized hydrogen peroxide to be an established sterilization method for medical devices.
Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biolo...
