FDA Grants Vitality Biopharma Orphan Drug Designation for VBX-100 Prodrug
August 10, 2021 09:00 ET
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Vitality Biopharma, Inc
CLEVELAND, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Vitality Biopharma, Inc. (OTC: VBIO) (“Vitality” or the “Company”), an innovation-driven drug development company dedicated to unlocking the therapeutic...
Spinogenix Granted FDA Orphan Drug Designation for SPG302 for the Treatment of Amyotrophic Lateral Sclerosis
June 07, 2021 07:00 ET
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Spinogenix, Inc.
SAN DIEGO, June 07, 2021 (GLOBE NEWSWIRE) -- Spinogenix, Inc. a pharmaceutical company focused on the development of novel synaptogenic small molecule therapies for central nervous system disorders...
Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of Acute Myeloid Leukemia (AML)
April 08, 2021 11:15 ET
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Aprea Therapeutics
BOSTON, April 08, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate...
European Commission Grants Ocugen Orphan Medicinal Product Designation for Gene Therapy Product Candidate, OCU400, For the Treatment of Both Retinitis Pigmentosa and Leber Congenital Amaurosis
February 23, 2021 07:30 ET
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Ocugen
MALVERN, Pa., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness...
Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST)
February 19, 2021 02:00 ET
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Immunicum AB
Pressmeddelande 19 februari 2021 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) Immunicum AB (publ;...
Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST)
February 19, 2021 02:00 ET
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Immunicum AB
Press Release 19 February 2021 Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) Immunicum AB (publ; IMMU.ST)...
Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting
September 21, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021 Extensive patient safety database, previously obtained...
Kiniksa Announces U.S. Orphan Drug Designation for Mavrilimumab for the Treatment of Giant Cell Arteritis
September 15, 2020 08:00 ET
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Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...
Merus announces FDA Orphan Drug Designation of Zenocutuzumab for the Treatment of Pancreatic Cancer
July 27, 2020 08:00 ET
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Merus N.V.
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific...
Kiniksa Announces U.S. Orphan Drug Designation for Rilonacept for the Treatment of Pericarditis
July 16, 2020 07:30 ET
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Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, July 16, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...