FDA publishes a draft guidance on obtaining postmarketing safety and effectiveness information on drugs in historically underrepresented patient popul...
FDA adds four new and updates nine existing tools in its medical device regulatory science tools catalog.
Datascope/Maquet/Getinge recalls the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps because they may shutdown without warning due to electric...
FDA clears an Accuray 510(k) for its VitalHold breast cancer package and its use on the companys Radixact radiation therapy system.
FDA approves a ZimVie PMA supplement for a smaller height of its Mobi-C Cervical Disc in seven sizes to address the anatomical needs of diverse patien...
FDA posts a draft guidance on biosimilar development formal meetings between the agency and sponsors.
PhRMA tells FDA it strongly agrees with the potential benefits of artificial intelligence and machine learning, among three other public commenters vi...
Novartis says top-line data from two Phase 3 studies evaluating remibrutinib 25 mg in patients with chronic spontaneous urticaria met their primary en...
