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orphan drugs

FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade

FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade

RAPS.org

opioid use disorder

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Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension

Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension

Pharmaceutical Business Review

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Who will be the biggest pharma players in orphan drugs?

Who will be the biggest pharma players in orphan drugs?

Pharmaforum

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AstraZeneca’s Fasenra gets FDA ODD status for eosinophilic oesophagitis

AstraZeneca’s Fasenra gets FDA ODD status for eosinophilic oesophagitis

Pharmaceutical Business Review

eosinophilic esophagitis

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AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer

AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer

Pharmaceutical Business Review

small cell lung cancer

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Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD

Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD

Pharmaceutical Business Review

Reata Pharmaceuticals

autosomal dominant polycystic kidney disease

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Orphan drugs market to soar to $224bn by 2024

Orphan drugs market to soar to $224bn by 2024

PM Live

Evaluate Pharma

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Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!

Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!

FDA Law Blog

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Report: Evaluating the Cost-Effectiveness and Controversies of Orphan Drugs

Report: Evaluating the Cost-Effectiveness and Controversies of Orphan Drugs

BioSpace

Orphan Drug Act

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Clinical Costs for Orphan Drugs Lower Than Non-Orphan Drugs, Study Finds

Clinical Costs for Orphan Drugs Lower Than Non-Orphan Drugs, Study Finds

RAPS.org

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New Industry Report Finds Most Orphan Drugs Aren't Successful

New Industry Report Finds Most Orphan Drugs Aren't Successful

BioSpace

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FDA Faulted For Lapses In Orphan Drug Program

FDA Faulted For Lapses In Orphan Drug Program

NPR

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Astrazeneca's Fasenra Gets Orphan Drug Designation for Autoimmune Disease

Astrazeneca's Fasenra Gets Orphan Drug Designation for Autoimmune Disease

Yahoo/Zacks.com

eosinophilic granulomatosis with polyangiitis

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Failed as a Cancer Treatment - Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1

Failed as a Cancer Treatment - Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1

CP Wire

Array Biopharma

neurofibromatosis

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FDA Finalizes Guidance Closing Pediatric Study Loophole

FDA Finalizes Guidance Closing Pediatric Study Loophole

RAPS.org

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Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union

Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union

CP Wire

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Seattle Genetics Announces Results of Two Ph II Trials of Tucatinib in HER2- Positive Metastatic Breast Cancer

Seattle Genetics Announces Results of Two Ph II Trials of Tucatinib in HER2- Positive Metastatic Breast Cancer

CP Wire

Seattle Genetics

clinical trials

HER2-positive metastatic breast cancer

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Tetra Discovery Partners Initiates Ph II Trial of Fragile X Syndrome Drug

Tetra Discovery Partners Initiates Ph II Trial of Fragile X Syndrome Drug

CP Wire

Tetra Discovery Partners

Fragile X syndrome

clinical trials

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Eagle Receives Orphan Drug Designation for Bendeka

Eagle Receives Orphan Drug Designation for Bendeka

CP Wire

Eagle Pharmaceuticals

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Are Orphan Drugs Getting Too Much Attention By Payers And Policymakers?

Are Orphan Drugs Getting Too Much Attention By Payers And Policymakers?

Forbes

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