Elevar Therapeutics files an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 fusions ...
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...
FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the proc...
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.
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...
University of Southern California public policy professor Genevieve Kanter airs concerns about the impact of the many changes that have occurred at FD...
FDA approves Tenpoint Therapeutics Yuvezzi as the only combination eye drop approved to treat presbyopia in adults.
