FDA grants Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer.
FDA warns Indias Intas Pharmaceuticals about CGMP and other violations at its drug manufacturing facility in Sanand, India.
FDA warns Alvin, TX-based Iso-Tex Diagnostics about CGMP violations in its production of finished drugs.
FDA warns Baxters Ahmedabad, India-based drug manufacturing facility about CGMP and other violations.
FDA clears a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device mild and moderate bleeding in cardiac surgical procedures a...
FDA approves a GSK supplemental BLA for Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by single-agent Jemperli for t...
FDA clears a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patients at risk for cardio...
FDA announces the FY 2024 user fee rates for medical device submissions.
