FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters based on an earl...
FDA warns Indias Somerset Therapeutics about CGMP and Field Alert Reporting violations in its production of finished drugs.
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FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developing such products.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...
