FDA accepts for priority review an Eli Lilly NDA for abemaciclib, a cyclin-dependent kinase 4 & 6 inhibitor for two indications in breast cancer.
A House Energy and Commerce subcommittee hears differing opinions on whether to advance two bills that would open up FDAs regulatory framework to allo...
The House of Representatives passes a bill (voice vote) to reauthorize medical product user fee programs for another five years beginning 10/1.
FDA warns Indias Vista Pharmaceuticals about CGMP and misbranding violations in its production of a finished pharmaceutical.
Federal Register notice: FDA requests comment on draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control data elements and termi...
Vifor Fresenius asks FDA not to approve a Keryx sNDA for its Auryxia that would expand its market, citing to multiple safety concerns.
Federal Register notice: FDA determines that the regulatory review period for Cerus Corp.s Intercept Blood System For Plasma is 6,497 days.
Federal Register notice: FDA determines that the regulatory review period for Cerus Corp.s Intercept Blood System for Platelets is 7,080 days.