orphan drugs

Celularity Gains FDA Orphan Drug Status on Strength of Placental Stem Cell Trials
Celularity Gains FDA Orphan Drug Status on Strength of Placental Stem Cell Trials
BioSpace
Celularity
FDA
orphan drugs
natural killer cells
malignant glioma
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Bill to close orphan drug loophole clears House
Bill to close orphan drug loophole clears House
Beckers Hospital Review
legislation
orphan drugs
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Sanofi grapples with rejection of potential first-in-class orphan drug, faults third-party manufacturing
Sanofi grapples with rejection of potential first-in-class orphan drug, faults third-party manufacturing
Endpoints
Sanofi
sutimlimab
orphan drugs
FDA
drug manufacturing
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Forma Therapeutics gets European orphan drug status for FT-4202 to treat sickle cell disease
Forma Therapeutics gets European orphan drug status for FT-4202 to treat sickle cell disease
Pharmaceutical Business Review
Forma Therapeutics
orphan drugs
Europe
FT-4202
sickle cell disease
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Orphan drug incentives reviewed at BIO
Orphan drug incentives reviewed at BIO
RAPS.org
BIO 2020
orphan drugs
drug development
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Gilead Asks the FDA to Rescind Orphan Drug Designation for Remdesivir as a Treatment for COVID-19
Gilead Asks the FDA to Rescind Orphan Drug Designation for Remdesivir as a Treatment for COVID-19
Motley Fool
Gilead Sciences
remdesivir
FDA
orphan drugs
COVID-19
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The biggest challenges facing rare disease pharma – and how the industry can tackle them
The biggest challenges facing rare disease pharma – and how the industry can tackle them
Pharmaforum
Rare Diseases
orphan drugs
drug development
FDA
drug pricing
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AstraZeneca’s Combination Treatment for HCC Snags Orphan Drug Designation
AstraZeneca’s Combination Treatment for HCC Snags Orphan Drug Designation
BioSpace
AstraZeneca
Imfinzi
orphan drugs
FDA
hepatocellular carcinoma
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FDA to Allow Online Submissions of Orphan Designation Requests
FDA to Allow Online Submissions of Orphan Designation Requests
RAPS.org
FDA
orphan drugs
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‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity
‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity
RAPS.org
FDA
orphan drugs
orphan exclusivity
Neurelis
Valtoco
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FDA: 2019 Continues Uptick in Orphan Drug Approvals
FDA: 2019 Continues Uptick in Orphan Drug Approvals
RAPS.org
FDA
drug approvals
orphan drugs
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FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
RAPS.org
FDA
orphan drugs
Indivior
Sublocade
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
Acceleron
orphan drugs
sotatercept
PAH
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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
orphan drugs
Roche
M&A
AbbVie
JNJ
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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
AstraZeneca
Fasenra
orphan drugs
FDA
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
AstraZeneca
Imfinzi
FDA
small cell lung cancer
orphan drugs
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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
ADPKD
autosomal dominant polycystic kidney disease
Bardoxolone
orphan drugs
FDA
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Orphan drugs market to soar to $224bn by 2024
Orphan drugs market to soar to $224bn by 2024
PM Live
orphan drugs
Zolgensma
LentiGlobin
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
orphan drugs
FDA
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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 drugs
Orphan Drug Act
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