FDA approves a BioVex BLA supplement to update the adverse drug reactions for its talimogene laherparepvec melanoma treatment.
FDA grants Merit Medical Systems a breakthrough device designation for its Scout MD Surgical Guidance System.
The Government Accountability Office calls on FDA and the HHS Office of Human Research Protections to take steps to improve their oversight of institu...
HHS directs FDA to work with CMS Innovation Center to test a proposed model that would adjust Medicare payments for accelerated approval drugs to expe...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers Aliqopa (copanlisib dihydrochloride).
Federal Register notice: FDA posts a list of 18 information collections that have been approved by OMB.
FDA releases the 2022 medical countermeasures annual report covering 14 key agency activities to support the development of and access to medical coun...
FDA says Concert Pharmaceuticals deuruxolitinib can retain its breakthrough therapy designation to treat alopecia areata.
