Federal Register notice: FDA extends the comment period on a 12/22 notice for its Master Protocols for Drug and Biological Product Development draft g...
FDA grants accelerated approval to Iovance Biotherapeutics for Amtagvi, a cellular therapy indicated for treating certain adult patients melanoma.
FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some diabetes patients.
FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in abnormal breast tissu...
FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.
Federal Register notice: FDA announces that its Office of Digital Transformation has modified its organizational structure.
FDA publishes for public comment 29 new and 33 revised product-specific guidances.
FDA commissioner Robert Califf says the recent worldwide reporting of a call to end Covid vaccines by the Florida surgeon general is an example of the...
