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617,623 Results for "gc pharma formerly known as green cross".
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Policy
FDA Grants Fast Track Designation to GCBP and Novel Pharma’s GC1130A
GC Biopharma and Novel Pharma have announced that the U.S. FDA has granted Fast Track Designation for their jointly developed MPSIIIA treatment, GC1130A.
June 10, 2024
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4 min read
Policy
GC Biopharma/Novel Pharma’s Sanfilippo Syndrome Treatment Obtains FDA IND Approval
GC Biopharma and Novel Pharma announced that its jointly developed MPS IIIA ‘GC1130A’ treatment has received FDA IND approval.
May 20, 2024
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2 min read
Policy
GC Biopharma/Novel Pharma’s Sanfilippo Syndrome Treatment Obtains FDA IND Clearance
GC Biopharma and Novel Pharma have announced that the U.S. FDA has cleared the investigational new drug application for their jointly developed MPSIIIA treatment, GC1130A.
May 21, 2024
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2 min read
Approvals
ARS Pharma Gets FDA Green Light for First Nasal Spray for Severe Allergic Reactions
ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.
August 12, 2024
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2 min read
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Tristan Manalac
Press Releases
GC Biopharma and Novelty Nobility Enter into Joint Research and Development Agreement for Geographic Atrophy Therapies
October 28, 2024
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3 min read
Press Releases
GC Biopharma and Hanmi Pharmaceutical Receives IND Clearance for Phase 1/2 Clinical Trial from the U.S. FDA
September 3, 2024
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3 min read
Policy
European Medicines Agency (EMA) Grants Orphan Drug Designation (ODD) to GC Biopharma’s Treatment for Sanfilippo Syndrome (Type A)
GC Biopharma Corp. announced that the European Medicines Agency has granted Orphan Drug Designation to its intracerebroventricular Enzyme Replacement Therapy candidate, GC1130A, designed for Sanfilippo Syndrome type A, developed in collaboration with Novel Pharma.
January 22, 2024
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2 min read
Business
GC Cell Signs an MOU with PT Bifarma Adiluhung, an affiliate of KALBE group
GC Cell, a fully integrated cell and gene therapy pioneer, is proud to announce the establishment of an MOU for strategic partnership with Bifarma, a frontrunner in stem cell therapy within Indonesia with comprehensive capabilities in R&D, GMP-compliant manufacturing, and the commercialization of cell therapies.
June 19, 2024
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4 min read
Business
Astellas Pharma Opens Cambridge Life Sciences Center Featuring Incubator Space
Astellas Pharma’s new life sciences center houses its first U.S.-based SakuLab, an incubator space for external partners, as well as its engineered small molecules unit.
September 6, 2024
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1 min read
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Angela Gabriel
FDA
GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
GC Biopharma Corp announces that the US Food and Drug Administration has approved ALYGLO 10% Liquid, formerly referred to as “GC5107,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency.
December 17, 2023
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9 min read
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