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...
Dr. Reddys Laboratories recalls one lot of levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL single-dose infusion bags because they ar...
Smiths Medical recalls its Portex Endotracheal Tube because some devices have a smaller diameter than expected and may result in inadequate ventilatio...
Just-appointed FDA chief counsel Hilary Perkins abruptly resigns her post after two days on the job.
