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.
Based on recent disappointing study data, Neurocrine Biosciences says it is stopping the development of two drugs being evaluated for treating focal o...
