FDA grants Abeona Therapeutics a fast track designation for ABO-202, a novel one-time AAV9 gene therapy for CLN1 disease.
FDA clears a Life Spine 510(k) for the Prolift Lateral Expandable Spacer System for use in treating spinal disorders.
The Association for Accessible Medicines encourages the U.S. trade representative to continue to keep pharmaceuticals and some pharmaceutical inputs o...
FDA grants Merck accelerated approval for Keytruda (pembrolizumab) and its use in treating certain patients with metastatic small cell lung cancer.
Researchers say there is no significant difference in drug development time between small molecule drugs and biologics.
FDA warns Tropical Seas about CGMP and other violations in its manufacturing of several over-the-counter drugs.
Federal Register notice: FDA seeks comments on an information collection extension for Data to Support Social and Behavioral Research as Used by the F...
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Postmarket Surveillance of Medical Devices 21 CFR Par...