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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 | 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...
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Corbus Pharmaceuticals Reports Last Subject Visit in DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis
March 30, 2021 08:05 ET | 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,...
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Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency
March 23, 2020 08:00 ET | 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...
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Biofrontera provides clinical development updates
February 19, 2020 05:45 ET | 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...
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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 | 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...
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The European Medicines Agency accepts the regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukemia
January 02, 2020 01:00 ET | INNATE PHARMA
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
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L'agence européenne du médicament accepte le dossier de demande d'enregistrement réglementaire de Lumoxiti dans la leucémie à tricholeucocytes en rechute ou réfractaire
January 02, 2020 01:00 ET | INNATE PHARMA
Innate Pharma SA (Euronext Paris : IPH – ISIN : FR0010331421 ; Nasdaq : IPHA) (« Innate » ou la « Société ») annonce aujourd’hui que l’Agence Européenne du Médicament (EMA) a accepté le dossier de...
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Biofrontera shows robust growth during first six months of 2019
August 27, 2019 02:15 ET | Biofrontera AG
Leverkusen, Germany, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today reported its...
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EMA Grants Orphan Drug Designation to Rafael Pharmaceuticals’ devimistat (CPI-613®) for Treatment of Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
January 10, 2019 11:00 ET | Rafael Pharmaceutical Inc.
Newark, NJ, Jan. 10, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc., a leader in the growing field of cancer metabolism-based therapeutics, today announced that the European Medicines Agency...
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EMA Grants Orphan Drug Designation to Rafael Pharmaceuticals’ devimistat (CPI-613®) for Treatment of Metastatic Pancreatic Cancer
January 10, 2019 08:00 ET | Rafael Pharmaceutical Inc.
Newark, NJ, Jan. 10, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc., a leader in the growing field of cancer metabolism-based therapeutics, today announced that the European Medicines Agency...