A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting ...
FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma.
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committe...
FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotexs sterile drug facil...
CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine withi...
An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients with advanced heart fa...
FDA publishes a guidance on implementing the eCopy submission program for medical devices.
FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices covered through a new Ce...
