FDA lifts a clinical hold against Beam Therapeutics and its BEAM-201 for treating relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymph...
FDA sends Cutera a Warning Letter related to marketing material that appeared on a company owned Web site about uncleared gynecological indications, i...
A Medtronic Dear Doctor letter describes a potential issue with the driveline cover in its HeartWare Ventricular Assist Device.
Lilly says its investigational Alzheimers drug donanemab outperformed Biogens Aduhelm in clearing brain amyloid in a Phase 3 comparator study.
FDA accepts for priority review an Innoviva NDA for intravenous Sul-Dur (sulbactam and durlobactam) for treating infections caused by Acinetobacter b...
Argenx pruchases a Priority Review Voucher from Bluebird Bio for $102 million, which Argenx plans to use for a planned BLA for efgartigimod, which it ...
Mayer Brown attorney George OBrien calls on FDA to take steps to respond to a 2021 11th Circuit Court of Appeals decision throwing out the agencys ind...
The Sedgwick second quarter recall index shows that medical device recalls hit a two-year high, while pharmaceutical recalls remained flat.
