The Reagan-Udall Foundation recommends steps to be taken by FDA and other stakeholders to improve evidence generation in postmarket studies.
House Energy and Commerce Committee Republicans threaten FDA with a subpoena if it continues to delay submitting documents on what they consider risky...
BridgeBio Pharma says it will file by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acoramidis in transthyre...
Novo Nordisk says data from its landmark Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly Wegovy showed that the drug...
FDA clears an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analytics tool.
FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to include adductor canal blo...
FDA gives Brixton Biosciences a breakthrough device designation for its Coolio Therapy, which is intended to deliver long-lasting pain control in targ...
Covidien recalls its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale illegally.
