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.
FDA releases the form FDA-483 with nine observations from an inspection at the Edmond, OK-based Qualgen outsourcing facility.
FDA approves an Enovis PMA for the STAR Patient Specific Instrumentation and its use with the companys STAR total ankle replacement system.
Federal Register notice: HHS delegates to FDA and NIH authorities under the Accelerating Access to Critical Therapies for ALS Act to establish and imp...
