https://www.pharmaceuticalprocessingworld.com/epicept-pain-drug-gets-fda-orphan-drug-designation/
EpiCept Pain Drug Gets FDA Orphan Drug Designation - Pharmaceutical Processing World
Oct 11, 2019 - TARRYTOWN, N.Y. (AP) — EpiCept Corp. said Wednesday the Food and Drug Administration granted the company’s developing pain drug orphan drug designation. The...
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https://www.ema.europa.eu/hr/medicines/human/orphan-designations/eu-3-19-2182
EU/3/19/2182 - orphan designation for treatment of primary biliary cholangitis | European Medicines...
Sep 8, 2022 - On 25 July 2019, orphan designation EU/3/19/2182 was granted by the European Commission to Genfit, France, for elafibranor for the treatment of primary biliary...
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https://www.cgtlive.com/view/fda-grants-orphan-designation-to-cynk-001-for-gbm
FDA Grants Orphan Designation to CYNK-001 for GBM | CGTlive®
Oct 11, 2026 - The FDA has granted an orphan drug designation to CYNK-001 as a potential treatment for adult patients with recurrent glioblastoma multiforme.
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https://www.cgtlive.com/view/clbs12-granted-orphan-designation-for-thromboangiitis-obliterans
CLBS12 Granted Orphan Designation for Thromboangiitis Obliterans | CGTlive®
Oct 13, 2026 - The FDA has granted an orphan drug designation to the CD34+ cell therapy CLBS12 as a potential treatment for patients with thromboangiitis obliterans.
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https://peptidestaff.com/regulatory-compliance/peptide-drug-orphan-designation-process/
Peptide Drug Orphan Designation Process: How to Get FDA Orphan Drug Status | PeptideStaff
Apr 21, 2026 - Peptide staffing, workforce solutions, and industry insights. Expert guidance for building your peptide research and manufacturing team.
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https://salesandmarketingnetwork.com/news_release_bs.html?pipe=0000ac177000191&ID=2020165&key=narcolepsy+
News for Medical Sales Reps: FDA Grants Orphan Drug Designation to TREANDA, an Investigational...
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https://www.kgi.edu/news/2015/fda-awards-kgi-an-orphan-drug-designation-for-rett-syndrome.html
FDA Awards KGI an Orphan Drug Designation for Rett Syndrome
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https://www.news-medical.net/news/20131029/Pharmalinks-Busulipo-receives-FDA-orphan-drug-designation.aspx
Pharmalink's Busulipo receives FDA orphan drug designation
Jun 24, 2019 - Pharmalink AB, a specialty pharma company focused on orphan and niche products, today announces its product Busulipo, a best-in-class conditioning agent for...
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https://friedreichsataxianews.com/news/leriglitazone-earns-european-commissions-orphan-drug-designation-for-fa/
Leriglitazone Earns Orphan Drug Designation for FA in Europe
Nov 14, 2019 - Minoryx Therapeutics’ investigational therapy leriglitazone (MIN-102) has been granted orphan drug designation in Europe for treating Friedreich’s ataxia.
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https://www.beyangtx.com/index.php?c=content&a=show&id=173
FDA Grant Orphan Drug Designation to BY002 for the Treatment of Acute Myeloid Leukemia (AML) with...
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https://www.einpresswire.com/article/869748119/fda-grants-orphan-drug-designation-to-novelwise-s-nbm-bmx-for-uveal-melanoma
FDA Grants Orphan Drug Designation to NovelWise’s NBM-BMX for Uveal Melanoma
Nov 24, 2025 - NovelWise received FDA Orphan Drug Designation for NBM-BMX, its selective HDAC8 inhibitor for uveal melanoma, strengthening momentum after Fast Track status.
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https://salesandmarketingnetwork.com/news_release_bs.html?pipe=0000ac177000191&ID=2018492&key=Orphan+Medical
News for Medical Sales Reps: Novagali Pharma Receives US FDA Orphan Drug Designation for Vekacia(R)...
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https://www.fiercebiotech.com/biotech/aerial-biopharma-receives-fda-orphan-drug-designation-for-narcolepsy-drug-development
Aerial BioPharma Receives FDA Orphan Drug Designation for Narcolepsy Drug in Development | Fierce...
Aug 29, 2012 - News Follows Successful Phase IIa Study Results Aerial BioPharma Receives FDA Orphan Drug Designation for Narcolepsy Drug in Development
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https://www.healthcaretodaymichigan.com/article/854568470-aavantgarde-announces-fda-orphan-drug-designation-and-uk-cta-approval-for-aavb-039-for-the-treatment-of-stargardt-disease
AAVantgarde Announces FDA Orphan Drug Designation and UK CTA approval for AAVB-039 for the...
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https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-sh-110-for-oral-suspension-in-glioma
FDA Grants Orphan Drug Designation to SH-110 for Oral Suspension in Glioma | OncLive
Oct 8, 2026 - SH-110 received orphan drug designation from the FDA for the treatment of patients with glioma.
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https://neuageinstitute.com/study/courses/ip-qara-2-project-two/
Orphan Drug Designation Request Form - NeuAge Institute (NAI)
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https://www.fshdsociety.org/zh/2018/07/18/acceleron-receives-fda-orphan-drug-designation-for-ace-083/
Acceleron Receives FDA Orphan Drug Designation for ACE-083 - FSHD Society
Feb 2, 2021 - From BusinessWire CAMBRIDGE, Mass.--(BUSINESS WIRE)--Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development...
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https://biotechdispatch.com.au/news/chimeric-secures-key-orphan-drug-designation-paving-the-way-for-accelerated-development
Chimeric secures key orphan drug designation, paving the way for accelerated development - Biotech
Chimeric Therapeutics (ASX:CHM) has achieved a significant regulatory milestone, announcing it has secured FDA Orphan Drug Designation for its lead candidate,...
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https://zonamedica.expedientevirtual.com/fda-grants-efzofitimod-orphan-drug-designation-for-systemic-sclerosis/
FDA grants efzofitimod orphan drug designation for systemic sclerosis – Zonamedica
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https://molefypharma.com/en/news/molefy-pharma-orphan-drug-designation-als/
Molefy Pharma receives Orphan Drug Designation (ODD) from the European Union for its AP-2 candidate...
Jul 1, 2026 - The EMA grants Molefy Pharma the Orphan Drug Designation for AP-2, a promising therapy for ALS that advances innovative rare disease treatments from Spain.
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https://www.curefa.org/news/minoryx-therapeutics-receives-fda-orphan-drug-designation-for-leriglitazone-in-friedreichs-ataxia/
Minoryx Therapeutics receives FDA Orphan Drug Designation for leriglitazone in Friedreich’s Ataxia...
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