House Energy and Commerce Committee Republicans ask for a GAO review of laboratory safety in FDA, CDC, and NIH, citing previous GAO recommendations th...
FDA warns two firms in Taiwan and Australia about Quality System violations in their manufacturing of x-ray equipment.
FDA sends Intercept Pharmaceuticals a complete response letter on its supplemental NDA for Ocaliva (obeticholic acid) seeking to convert its accelerat...
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.
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...
