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FDA Roundup: May 31, 2024

FDA Roundup: May 31, 2024
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United States , Eli Lilly , Health Data In Medical Device Development , Autonomous Medical Systems Saams Collaborative Community , Office Of Media Affairs , Drug Administration , Moderna Modernatx Inc , Pilot Program , Openoximetry Collaborative Community , Juno Therapeutics Inc , Digital Medicine Society , Computer Interface Collaborative Community , Centers For Medicare Medicaid Services , Centers For Disease , Respiratory Syncytial Virus Vaccine , Safeguarding Therapeutics Act , Drug Omnibus Reform Act , Consolidated Appropriations Act , Federal Food , Autonomous Medical Systems , Juno Therapeutics , Risk Evaluation , Mitigation Strategy , Clinical Trials Advancing Rare , Biologics Evaluation , Drug Evaluation ,

Jazz Pharmaceuticals Showcases Pioneering Research in Sleep Medicine at SLEEP 2024

Jazz Pharmaceuticals Showcases Pioneering Research in Sleep Medicine at SLEEP 2024
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United States , Kelvin Tan , Andrean Flynn , Kristin Bhavnani , A Survey Of Patients , National Health Service , Jazz Pharmaceuticals , Analysis Of The National Health , International Classification Of Sleep Disorders , Drug Administration , National Academies Press , United States Drug Enforcement Agency , Drug Enforcement Agency , Jazz Pharmaceuticals Inc , Office Of Orphan Product Development , American Academy Of Sleep Medicine , Us National Health , Indian Journal Of Medical Research , American Psychiatric Association , Unmet Public Health Problem , National Institute Of Neurological Disorders , Associated Professional Sleep Societies , Wellness Survey , Switch Study From , Low Sodium Oxybate Evaluating Blood Pressure , Low Sodium Oxybate ,

U.S. Food and Drug Administration Approves Bristol Myers Squibb's Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma

U.S. Food and Drug Administration Approves Bristol Myers Squibb's Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma
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United States , United Kingdom , Bristol Myers Squibb , John Cunningham , Bryan Campbell , Hemophagocytic Lymphohistiocytosis , Michael Wang , Meghan Gutierrez , Lymphoma Research Foundation , European Union , Exchange Commission , University Of Texas Md Anderson Cancer Center , Department Of Lymphoma , Drug Administration , Division Of Cancer Medicine , Important Safety Information , Cytokine Release Syndrome , Neurologic Toxicities , Secondary Hematological , Cell Therapy , Bristol Myers , Puddin Clarke Endowed Professor , Cancer Medicine , Cancer Center , Clinical Oncology , Lymphoma Research ,

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS
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Sarah Yim , Office Of Therapeutic Biologics , Drug Administration , Amgen Inc , Alexion Pharmaceuticals , Therapeutic Biologics , Drug Evaluation , Boxed Warning , Risk Evaluation , Mitigation Strategy ,

FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris

The approval was supported by data from the double-blind, active-controlled, 2-period crossover, phase 3 DAHLIA study. ....

Drug Administration , Boxed Warning , Risk Evaluation , Mitigation Strategy ,