FDA extends by three months the review of a Valneva BLA for VLA1553, the companys chikungunya virus vaccine candidate.
Federal Register notice: FDA announces a modification to the organizational structure of CDRHs Office of Strategic Patnerships and Technology Innovati...
Federal Register notice: FDA announces a 9/7-8 Medical Devices Advisory Committee Microbiology Devices Panel meeting that will discuss certain in vitr...
Philips Respironics recalls its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt in the air path of some device...
FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager for t...
FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility cited significant GMP ...
FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.
FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for treating invasive aspe...
