FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients with recessive dystro...
Federal Register notice: FDA determines that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due to safety or effect...
Federal Register notice: FDA announces a 12/12 public workshop titled Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drug...
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.
