FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned ...
FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the proc...
A group of Democratic senators ask HHS Office of Inspector General to clarify how it will oversee direct-to-consumer prescription drug sales tied to t...
Sen. Rick Scott (R-FL) introduces legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmac...
Ultragenyx Pharmaceutical resubmits a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A...
Elevar Therapeutics files an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 fusions ...
Grail files the final module of its PMA for the companys multi-cancer early detection blood test.
FDA awards Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythematosus.
