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...
Ombu Enterprises petitions FDA to make unique device identifier information publicly available in the MAUDE and Recall databases.
A bipartisan Senate letter urges FDA commissioner Robert Califf and HHS secretary Xavier Becerra to step up efforts to help resolve amoxicillin and ot...
