Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and medical device clinica...
FDA posts a Medtronic update on its NIM electromyogram endotracheal tubes, including actions to take in the event of airway obstruction.
An FDA safety alert warns about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the...
FDA approves a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patie...
United Therapeutics sues FDA over its decision to permit Liquidia to seek a second indication for its Yutrepia by amending its pending NDA rather than...
Federal Register notice: FDA amends its standing advisory committee regulations to add the new Digital Health Advisory Committee.
FDA warns Chinas Sichuan Deebio Pharmaceutical Co. about significant deviations in manufacturing active pharmaceutical ingredients.
A report of a patients liver failure leads to an FDA clinical hold against two RAPT Therapeutics Phase 2 trials involving zelnecirnon (RPT193).
