FDA grants BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms ...
Federal Register notice: FDA announces a 9/18-19 public workshop entitled Optimizing the Use of Postapproval Pregnancy Safety Studies.
A sharply-worded Vanda response to FDA says commissioner Robert Califf should reject a CDER proposed order and either approve Vandas sNDA for a Hetlio...
The Segwick Recall Index shows that both medical device and drug recalls dropped in the second quarter of 2023 from the first quarter.
FDA grants Nuvectis Pharmas NXP800 an orphan drug designation for treating biliary tract cancer.
FDA clears a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope.
FDA says it will give priority review to a Servier sNDA seeking a new indication for Tibsovo to treat some adult myelodysplastic syndrome patients.
