FDA issues Pharming Group a complete response letter for its supplemental NDA seeking expanded approval of Joenja (leniolisib) for children aged 4 to ...
Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after receiving final agency...
FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.
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...
FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned ...
