FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.
Federal Register notice: FDA announces the Cellular and Gene Therapies Interactive Site Tours Program that is intended to give CBER reviewers an oppor...
FDA grants Sumitomo Pharma America a fast track designation for DSP-5336 and its use in treating certain patients with relapsed or refractory acute my...
Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical artificial intelligen...
Citing payor management concerns, Indivior says it is discontinuing sales and marketing for schizophrenia drug Perseris (risperidone).
Bausch+Lombs Synergetics unit recalls its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal (back of the eye) i...
Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmatory study failed to de...
FDA grants Bayer-owned Asklepios BioPharmaceutical a fast track designation for AB-1005, a gene therapy candidate for treating moderate Parkinsons dis...
