FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...
FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...
FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.
Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.
The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.
FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat heartworm in dogs.
FDA releases the form FDA-483 with six observations from an inspection at a Goa, India, Cipla drug manufacturing facility.
FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency through a new office in...
