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...
Eitan Medical recalls its Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues.
Federal Register notice: FDA sends to OMB an information collection extension entitled Orphan Drugs 21 CFR Part 316.
Based on high discontinuation rates in a just-reported clinical trial, Pfizer says it will not advance its twice-daily weight-loss drug danuglipron in...
