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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Su...[ 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The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.[ Price : $8.95]
FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery p...[ Price : $8.95]
FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.