FDA warns healthcare professionals about supply interruptions involving hemodialysis bloodlines.
Federal Register notice: FDA withdraws the approval of a Sage Therapeutics NDA for Zulresso (brexanolone) solution after it told the agency that the d...
Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they told the agency that the drugs were no longer marke...
Federal Register notice: FDA rejects a request for a hearing submitted by Bernardo Garmendia, and issues an order permanently debarring him from provi...
Becton Dickinsons CareFusion unit recalls its BD Alaris Systems Manager due to software issues that could provide incorrect therapy.
FDA awards Korro Bio an orphan drug designation for KRRO-110 for treating Alpha-1 Antitrypsin Deficiency.
FDA convenes a non-public interagency meeting to adopt recommendations for vaccine manufacturers and the virus strains to be used for the 2025-2026 U....
FDA approves a Valcare Medical IDE to assess the safety and functionality of its AMEND Trans-Septal System for treating patients with mitral insuffici...
