FDA revises Eli Lillys emergency use authorization for bamlanivimab and etesevimab and Regenerons emergency use authorization for Regen-Cov (casirivim...
Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance on Reagents for Detection of Specific Novel Influ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Exports Notification and Recordkeeping Requirements 21 CF...
FDA issues Merck a complete response letter on its NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refracto...
FDA places a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy.
FDA approves a Medtronic PMA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for treating chronic pain associate...
A Florida federal court sentences former clinical study coordinator Duniel Tejeda to 30 months in prison for his participation in a conspiracy to fals...