FDA sends Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imaging agent for clear ...
The Justice Department says a resident of India has been indicted on federal charges of trafficking in fake cancer drugs sold in the U.S.
The CDER Quantitative Medicine Center of Excellence posts four new resources.
Federal Register notice: FDA set biosimilar user fee rates for fiscal year 2025.
Federal Register notice: FDA posts the over-the-counter monograph order request fee rates for fiscal year 2025.
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Testing for the Develop...
CDER explains how it used artificial intelligence/machine learning (AI/ML) to help identify the patient population most likely to benefit from Sobis K...
FDA grants Zymedi an orphan drug designation for ZMA001, a monoclonal antibody in development for pulmonary arterial hypertension.
