FDA clears an Ulrich Medical 510(k) for its Flux-C 3D-printed porous titanium cervical interbody device.
Federal Register notice: FDA announces an opportunity for public comment on a statement of work to assess communication between FDA and sponsors throu...
Travere Therapeutics says it is expecting FDA to extend its review by three months of an accelerated approval-seeking NDA for sparsentan and its use i...
Revive Therapeutics finalizes an amended protocol for the companys Phase 3 clinical trial designed to evaluate the safety and efficacy of investigatio...
FDA accepts for review a BioMarin BLA resubmission for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A.
Federal Register notice: FDA seeks consumer organizations that are interested in participating in selecting voting and nonvoting consumer representati...
Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practice in Manufacturing, Pack...
Two Centers for Medicare and Medicaid Services officials describe the principles in a new coverage rule for innovative medical devices the agency is d...
