FDA commissioner Robert Califf tells Friends of Cancer Researchs annual meeting that he is personally disappointed in the election results and the pot...
Lilly calls on FDA to reject the Outsourcing Facilities Association nomination of tirzepatide to be on the 503 Bulks List so it can be compounded.
FDA removes a clinical hold on a Novavax IND for its Covid-19-influenza combination and stand-alone flu vaccine candidates.
FDA approves an Autolus Therapeutics BLA for Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for treating adult patients with lymphoblastic leukem...
Rapt Therapeutics terminates its zelnecirnon drug development program due to a serious liver safety issue.
FDA grants Johnson & Johnson a breakthrough therapy designation for nipocalimab and its use for treating Sjgren's disease.
AbbVie says its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia did not...
FDA posts an untitled letter sent to Brookfield Medical/Surgical Supplies due to GMP issues cited in a May inspection.
