Federal Register notice: FDA sends to OMB an information collection extension for Export of Medical Devices; Foreign Letters of Approval.
FDA accepts for priority review an Epizyme NDA seeking accelerated approval for tazemetostat, indicated for treating metastatic or locally advanced ep...
Media outlets report the Trump administration is considering an executive order to tie Medicare Part D drug prices to lower prices in other countries.
Federal Register notice: FDA seeks comments on the agencys publication of a glossary of terms which is part of the BEST (Biomarkers, Endpoints, and ot...
FDA approves an Eli Lilly NDA for Baqsimi (glucagon) nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglyce...
FDA accepts for review a resubmitted NDA for Correvios Brinavess to convert atrial fibrillation to sinus rhythm.
FDA clears a Life Spine 510(k) for the Prolift Expandable Spacer System.
FDA says Allergan has agreed to remove from the market certain of its textured breast implant products and tissue expanders due to an association with...