Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis recommendation that a clinical trial evaluating ulixacal...
Reps. Finstad and Crenshaw introduce legislation to stop FDA from regulating laboratory-developed tests.
An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms facility in Gagillapu...
Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can lead to device shut...
The Senate Health Education Labor & Pensions committee sets a 3/6 confirmation hearing to review the nomination of Johns Hopkins surgeon and public po...
In a move linked to HHS secretary Robert F. Kennedy Jr., FDA suddenly cancels a 3/13-planned Vaccines and Related Biological Products Advisory Committ...
FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.
FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in Lenoir, NC.
