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EC approves Chugai’s Enspryng for NMOSD treatment
pharmaceutical-technology
June 29, 2021
The European Commission (EC) has approved Chugai Pharmaceutical’s Enspryng (satralizumab) to treat anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD).
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Aeterna Zentaris Engages Dr. Michael Levy to Support Development of Autoimmune and Inflammatory CNS Disorders Programs
americanpharmaceuticalreview
June 09, 2021
Aeterna Zentaris Inc, a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, announced it has engaged neuroimmunologist, Michael Levy, MD, PhD, Research Director of the ...
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Highlights of the EMA’s human medicine committee meeting, April 2021
europeanpharmaceuticalreview
April 27, 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
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Roche’s Enspryng leads latest CHMP recommendations
pharmatimes
April 27, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended eight new medicines for approval in its April meeting.
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FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord
americanpharmaceuticalreview
August 21, 2020
The U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive.
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Roche receives FDA approval for Enspryng to treat NMOSD
pharmaceutical-technology
August 18, 2020
Roche has received approval from the US Food and Drug Administration (FDA) for Enspryng (satralizumab-mwge) to treat adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
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US FDA approves Enspryng from Genentech for neuromyelitis optica spectrum disorder
expresspharma
August 17, 2020
In two randomised controlled Phase III clinical trials, SAkuraStar and SAkuraSky studies, Enspryng demonstrated robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody-positive NMOSD.
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FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord
americanpharmaceuticalreview
June 23, 2020
The U.S. Food and Drug Administration (FDA) approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody.
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US FDA grants approval of Uplizna to Viela Bio
expresspharma
June 12, 2020
Uplizna is the second FDA approved therapy for Neuromyelitis Optica Spectrum Disorder which offers patients additional treatment option.
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FDA approves treatment for rare neurological disorder
europeanpharmaceuticalreview
July 05, 2019
An injection to treat NMOSD has been given approval by the FDA and has received orphan drug designation.