Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.
aTyr Pharma reports mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic inflammatory lung disease...
FDA grants Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan and its use for treating patients with certain forms...
Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-related issue that can ...
FDA approves a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to congestive heart failure...
FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firms Orlando, FL manufacturing facility.
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.
FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice of convening indepe...
