House Energy and Commerce Committee leaders ask FDA to explain its slower than expected progress with manufacturers and providers of stem cell product...
Bristol-Myers Squibb says a Phase 3 trial of its Opdivo failed to meet the primary clinical endpoint in specified lung cancer patients.
FDA finalizes an updated guidance on 510(k) submissions for metal expandable biliary stents.
Federal Register notice: FDA sets the generic drug user fee rates for fiscal year 2020.
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...