FDA accepts for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of riluzole for treating p...
FDA classifies as Class 1 an Oscor recall of its TB Temporary Bipolar Pacing Leads due to connector separation that may cause a loss of pacing.
FDA Review posts the Federal Register notices for the week ending 11/23/2018.
Four stakeholders comment on an FDA report on the servicing of medical devices.
AdvaMed submits line-by-line comments to FDA on a draft guidance on considering uncertainty in medical device benefit-risk determinations.
Federal Register notice: FDA announces an approval for Tevas Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults under a redeemed pr...
FDA approves Pfizers Daurismo to be used with low-dose cytarabine to treat some new cases of acute myeloid leukemia.
A CDRH report says there is improved medical device manufacturer compliance as a result of increased inspection oversight using a risk-based approach ...