CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers be removed from where they...
Two physicians affiliated with Stanford Universitys medical school urge FDA to approve carbetocin for preventing postpartum hemorrhage.
CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.
FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.
Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to improve the electronic health record capture of informa...
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated Stage II and III loca...
Three stakeholders provide their responses to an FDA Request for Information on the Operation TrialBlazer Expedited IND Pilot Project.
The Sedgwick Recall Index shows that in the first half of 2026, medical device and drug recalls fell, but the number of recalled units sharply increas...
