FDA releases a final guidance on Development and Submission of Near Infrared Analytical Procedures.
Federal Register notice: FDA announces its implementation of a court decision that ruled the agency is not afforded discretion when a combination prod...
Federal Register notice: FDA extends the period for states to decide whether to sign the final standard memorandum of understanding for compounded dru...
FDA sends Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related to manufacturing an...
Boston Scientific begins enrolling in the HI-PEITHO clinical trial to compare its EkoSonic Endovascular System in combination with anticoagulation the...
Researchers call on FDA to reconsider class suicide risk warnings for all epilepsy drugs.
FDA grants Apexigen an orphan drug designation for APX005M (sotigalimab) for treating soft tissue sarcoma.
Three FDA officials say the recent approval of Astellas Prograf for a new indication demonstrates that real-world data observational studies can be co...