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Federal Register notice: FDA announces that it has issued a priority review voucher to Genzyme after gaining a qualified approval ...[ Price : $8.95]
Federal Register notice: CBER modifies the organizational structures in the Office of Blood Research and Review and the Office of ...[ Price : $8.95]
FDA tells Travere Therapeutics that data appear to support a supplemental NDA to convert the companys accelerated approval to full...[ Price : $8.95]
FDA awards Johnson & Johnson a breakthrough therapy designation for TAR-200 for treating certain patients with Bacillus Calmette-G...[ Price : $8.95]
A House of Representatives subcommittee asks FDA commissioner Robert Califf for a staff-level briefing on why it took so long for ...[ Price : $8.95]
CDER says it is seeking to withdraw unresolved citizen petitions that have lingered for more than five years at the agency without...[ Price : $8.95]
Eitan Medical recalls its Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to softw...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Orphan Drugs 21 CFR Part 316.