FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab.
An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.
FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovascular procedure kits.
FDA solicits applications for its new READI-Home innovation challenge to use medical technology in the home to reduce or prevent hospital readmissions...
Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowering prescription drug ...
FDA agrees to hear an Outlook Therapeutics formal dispute resolution request regarding the agencys prior rejection of eye disease therapy Lytenava (be...
A federal judge declines to immediately restrict access to the abortion pill mifepristone, instead pausing a high-profile lawsuit brought by Louisiana...
FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.
