Federal Register notice: FDA seeks comments on an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CF...
FDA warns Bishop, CA-based NeuroField about Quality System and other violations in its manufacturing of neurostimulation and electroencephalogram sign...
FDA publishes a draft guidance with recommendations for sponsors submitting an IND to develop human gene therapy products incorporating genome editing...
Due to disappointing overall survival data, Merck has stopped its Phase 3 KEYLYNK-010 trial evaluating Keytruda in combination with Lynparza for treat...
FDA classifies as Class 1 a LuSys Laboratories recall of its Covid-19 antigen tests (nasal/saliva) and Covid-19 IgG/IgM antibody tests because they ar...
FDA publishes a draft guidance with CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology and toxicology; and ...
FDA approves Mylans generic Symbicort for asthma and COPD patients.
A Senate pandemic-related bill that outlines many new FDA responsibilities heads to the Senate floor for a vote after being marked-up 3/15 by Health, ...