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FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.[ Price : $8.95]
FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingred...[ Price : $8.95]
FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device ins...[ Price : $8.95]
FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 20 ANDAs from multiple applicants after they notified the agency that the drug ...[ Price : $8.95]
Jazz Pharmaceuticals says data from its Phase 2b clinical trial evaluating the efficacy and safety of suvecaltamide in adult patie...[ Price : $8.95]
Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.[ Price : $8.95]
FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants.