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FDA Approves Zilbrysq for Generalized Myasthenia Gravis

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Approval granted for once-daily, self-administered treatment in patients with anti-acetylcholine receptor-antibody-positive disease

FDA Approves Nivolumab as Adjuvant Treatment for Melanoma

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Approval granted for patients aged 12 years and older with stage IIB/C disease

FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults

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Significant benefits at 12 weeks include clinical remission, endoscopic improvement, mucosal healing

FDA Approves Updated Novavax COVID-19 Vaccine

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Updated shot is expected to better target variants that are circulating now and help prevent hospitalization and death from the virus

Even Five Years Postapproval, Many Drug Studies Remain Nonpublic

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Authors urge greater transparency of study results for drugs approved by the FDA

First Biosimilar Approved to Treat Multiple Sclerosis

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Tyruko, biosimilar to Tysabri (natalizumab) injection, approved for treatment of clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

FDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer

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Akeega plus prednisone significantly improves radiographic progression-free survival in patients with castration-resistant prostate cancer

FDA Provides Accelerated Approval of Talvey for Multiple Myeloma

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Talvey, a bispecific therapy, indicated for the treatment of patients with relapsed, refractory, heavily pretreated multiple myeloma

FDA Approves Izervay for Geographic Atrophy Tied to Age-Related Macular Degeneration

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Two trials show significant slowing of geographic atrophy progression at the 12-month primary end point

FDA Gives Approval to Pill to Ease Postpartum Depression

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Zurzuvae works faster than conventional antidepressants and is easier to take than another postpartum depression drug that is delivered intravenously