FDA approves an Immunocore BLA for Kimmtrak (tebentafusp-tebn) for treating certain adult patients with unresectable or metastatic uveal melanoma.
FDA places a partial clinical hold on Gilead Sciences studies evaluating the combination of magrolimab plus azacitidine (Celgenes Vidaza) due to an ap...
FDA warns Aurobindo Pharmaceutical about repeat CGMP deviations in the manufacturing of active pharmaceutical ingredients at its plant in Doultabad, T...
Former dissident CBER Office of Vaccines Research and Review deputy director Philip Krause joins Adjuvance Technologies as a strategic consultant.
FDA publishes a guidance on using patient engagement to support the design and conduct of medical device clinical studies.
Federal Register notice: FDA announces a 3/3 Vaccines and Related Biological Products Advisory Committee meeting that will select strains to be includ...
CBER releases a list of 13 guidances it is considering developing in 2022.
FDA tells Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline)...