Peter Marks, director of CBER, is pushing to get more gene therapies targeting rare diseases...
With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched...
Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases...
Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate...
Allergan must still face allegations that it violated the False Claims Act by incentivizing physicians...
A Senate committee has demanded answers from Danish pharma Novo Nordisk on what it labels...
A 3D-printed, patient-specific cranial implant solution received 510(k) clearance Monday from the FDA. South Carolina-based...
Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags...
Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou,...