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FDA GRANTS FULL APPROVAL FOR BLINCYTO® (BLINATUMOMAB) TO TREAT MINIMAL RESIDUAL DISEASE-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of...

Muscular Dystrophy Association Celebrates FDA Approval of argenx’s Vyvgart Hytrulo Injection for Treatment of Generalized Myasthenia Gravis

The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of subcutaneous (SC) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc),for the treatment of...

Arcellx Announces Clinical Hold for its iMMagine-1 Phase 2 Clinical Program

Arcellx, Inc., a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, announced that...

U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS (mavacamten) Label

Bristol Myers Squibb, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to add positive data from...

New Data from TEPEZZA (teprotumumab-trbw) Clinical Trials and Real-World Analyses Shed Light on Link Between Thyroid Autoimmunity and Hearing Risks

Horizon Therapeutics plc, announced the presentation of a series of analyses demonstrating the risk of hearing-related events among people with Graves’ disease and TED,...
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