FDA sets 2/22/2024 as the PDUFA action date for its priority review of Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to treat complicated ur...
FDA grants AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include the non-surgical rem...
Federal Register notice: FDA debars Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S.
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...
