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.
Federal Register notice: FDA issues a priority review voucher was issued to SpringWorks Therapeutics for achieving a 2/11 NDA approval for Gomekli (mi...
FDA warns Fremont, CA-based QApel Medical about illegally marketing an aspiration system with Quality System Regulation violations.
