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...
Cook Medical recalls its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received for balloons burstin...
FDA releases its latest batch of Warning Letters that includes PRL, Inc. and Tropical Seas.
FDA scientists say they have developed a new and improved poliovirus assay.