FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and vote on an Ipsen Biop...
FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapproved new drugs.
FDA releases the form FDA-483 with six observations from an inspection at Indias Jubilant Generics.
FDA clears a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) use for the recording,...
FDA approves AstraZenecas Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresectable liver cancer.
Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for developing topical drug products.
FDA determines there are insufficient data to support a proposed cefazolin susceptible minimum inhibitory concentration breakpoint of less than or equ...
