NurExone Biologic Secures EMA Orphan Status for ExoPTEN in Spinal Cord Injury, Accelerating Pathway to European Markets
November 13, 2024 16:14 ET
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NurExone Biologic Inc
European Medicines Agency Awards Orphan Status to NurExone's ExoPTEN for Spinal Cord Injury, Paving the Way to European Market Entry
Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
May 01, 2024 06:55 ET
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Janssen Cilag International NV
Media contact:Sophie DaneauSdaneau@its.jnj.com+33 6 3178 8798Investor contact:Raychel Kruperinvestor-relations@its.jnj.com For European and UK medical and trade media only For immediate...
Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy
February 23, 2024 07:05 ET
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Travere Therapeutics, Inc.
Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe ...
Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301
July 17, 2023 16:05 ET
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Aridis Pharmaceuticals, Inc.
LOS GATOS, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the European Medicines Agency (EMA) on the Company’s proposed...
Clinigen initiates a Managed Access Program for relugolix in Europe for the treatment of advanced hormone-sensitive prostate cancer
December 20, 2022 02:00 ET
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Clinigen
20 December 2022 Clinigen initiates a Managed Access Program for relugolix in Europe for the treatment of advanced hormone-sensitive prostate cancer Clinigen Limited (‘Clinigen’), the global...
Synlogic Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1618 for the Treatment of Phenylketonuria
May 24, 2022 07:00 ET
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Synlogic, Inc.
CAMBRIDGE, Mass., May 24, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its...
Corbus Pharmaceuticals Reports Last Subject Visit in DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis
March 30, 2021 08:05 ET
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Corbus Pharmaceuticals Holdings, Inc.
Topline data on schedule for Q2 2021Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, and affects ~80,000 people in North America, EU,...
Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency
March 23, 2020 08:00 ET
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Celsion CORP
Approval Adds 10 Years of Market Exclusivity Following Marketing Authorization in Europe LAWRENCEVILLE, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a leading...
Biofrontera provides clinical development updates
February 19, 2020 05:45 ET
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Biofrontera AG
Leverkusen, Germany, Feb. 19, 2020 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today provides an...
Monopar Therapeutics Receives Orphan Drug Designation from the European Commission for Camsirubicin in the Treatment of Soft Tissue Sarcoma
February 18, 2020 09:00 ET
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Monopar Therapeutics Inc.
CHICAGO, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ: MNPR) today announced it has been granted Orphan Drug Designation from the European Commission for its drug candidate...