A Center for Innovation in Regulatory Science briefing paper stresses Chinas faster drug approvals and the need for sponsors to make coordinated submi...
FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major pus...
FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developing such products.
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...
