[ Price : $8.95]
FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marn...[ Price : $8.95]
FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.[ Price : $8.95]
Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia...[ Price : $8.95]
The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.[ Price : $8.95]
FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat ...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at a Goa, India, Cipla drug manufacturing facility.[ Price : $8.95]
FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency thr...[ Price : $8.95]
FDA modifies the REMS for CAR T cell products to ease the burden on hospitals and their clinics.