Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical Devices 21 CFR Par...
Philips North America recalls its Sense XL Torso (1.5T and 3.0T) MRI coils to update use instructions due to a potential issue where the coil heats up...
Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingredients in NDAs and A...
Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that produced inaccuratel...
J&J touts positive overall survival results of its Carvykti in a Phase 3 trial in patients with relapsed or lenalidomide-refractory multiple myeloma a...
Checkpoint Therapeutics says it has completed the resubmission of a BLA for its cosibelimab cancer treatment.
FDA approves Samsung Bioepis Pyzchiva as an interchangeable biosimilar for Janssens Stelara.
FDA approves a Genentech Vabysmo prefilled syringe to treat three retinal disorders with the same medicine as Vabysmo vials.
