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...
Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early endpoint in clinical t...
FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that are unlicensed biol...
FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.
