FDA denies the Informed Consent Action Networks petition that the agency reconsider its response denying an earlier petition calling for changes to th...
Federal Register notice: FDA withdraws 2 Zydelig lymphoma indications that received accelerated approval because the firm failed to demonstrate a clin...
FDA issues a complete response letter to Verrica for its VP-102 dermatology NDA.
Three Hyman Phelps attorneys question as irresponsible FDAs decision to issue a safety communication about non-invasive prenatal tests without providi...
The Justice Department says a federal jury returned guilty verdicts for a former Florida pain doctor and a former Insys sales representative in a heal...
FDA grants a de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast cancer patient bloo...
FDA says research indicates that collaborative good clinical practice inspections by FDA and the European Medicines Agency provide comparable results.
Two former FDA attorneys say proposed BLOCKING legislation will not have its intended effect of accelerating generic drug entry into the marketplace.