FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) 100 mg & 50 mg tablets for treating certain adult patients with chronic lymphoc...
University researchers say there is a pressing need to explore alternative methods for inspecting overseas and domestic drug manufacturing facilities ...
Federal Register notice: FDA announces that it has issued a priority review voucher to Genzyme after gaining a qualified approval for Xenpozyme (olipu...
Federal Register notice: CBER modifies the organizational structures in the Office of Blood Research and Review and the Office of Vaccines Research an...
FDA tells Travere Therapeutics that data appear to support a supplemental NDA to convert the companys accelerated approval to full approval for Filspa...
FDA awards Johnson & Johnson a breakthrough therapy designation for TAR-200 for treating certain patients with Bacillus Calmette-Gurin-unresponsive hi...
A House of Representatives subcommittee asks FDA commissioner Robert Califf for a staff-level briefing on why it took so long for the agency to finall...
FDA clears a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device.
