Rheumatoid Arthritis Biosimilar Meets Equivalency Endpoints in Phase 1/3 Trial
January 25th 2019Rituximab is approved by the FDA for the treatment of adults with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
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FDA Accepts BLA for Spinal Muscular Atrophy Drug
December 3rd 2018Abeparvovec (Zolgensma) is a one-time infusion that replaces the defective or missing SMN1 gene with a functional copy that can create the SMN protein and prevent the loss of motor neurons in patients with spinal muscular atrophy.
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Investigational Antiviral Flu Drug Achieves Efficacy Goal in Phase 3 Trial
July 18th 2018The phase 3 CAPSTONE-2 study of the safety and efficacy of baloxavir marboxil in patients at high risk of complications due to influenza (flu) has met the primary objective of efficacy of a single dose of baloxavir marboxil compared to placebo.
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Updated Secukinumab Label to Include Evidence for Treatment of Psoriatic Arthritis
June 20th 2018The updated label includes new evidence that the treatment significantly impedes the progression of joint structural damage at 24 weeks compared to placebo for patients with active psoriatic arthritis.
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