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2019/11/04
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FDA Approves Armlupeg (pegfilgrastim-unne), a Biosimilar to Neulasta
FDA Approves Osvyrti (denosumab-desu), a Biosimilar to Prolia
FDA Approves Itvisma (onasemnogene abeparvovec-brve) Gene Replacement Therapy for Adults and Children Two Years and Older with Spinal Muscular Atrophy
FDA Approves Jubereq (denosumab-desu), a Biosimilar to Xgeva
FDA Grants Accelerated Approval for Voyxact (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression
FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade
FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults
FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions
FDA Approves Brukinsa (zanubrutinib) for the Treatment of Mantle Cell Lymphoma
PellePharm Completes Enrollment Of Pivotal Phase 3 Clinical Trial Of Patidegib Topical Gel In Patients With Gorlin Syndrome
Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine
The Medicines Company Announces that the ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing
New England Journal of Medicine Publishes Results of Ebola Clinical Trial Confirming Superiority of Regeneron's REGN-EB3 to ZMapp in Preventing Ebola Deaths
Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors
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