FDA approves a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis in patients with cor...
FDA affirms its regulation of fresh allograft heart valves in a just-posted letter to healthcare professionals.
Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations relate...
FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder...
FDA classifies as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says i...
FDA approves an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections.
FDA updates a Class 1 recall (correction) of Megadyne Medical Products Mega Soft patient return electrode models to reiterate the devices should not b...
FDA posts a draft guidance on Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institution...
