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...
CDER says it is seeking to withdraw unresolved citizen petitions that have lingered for more than five years at the agency without producing formal re...
