orphan drugs

FDA grants orphan drug designation to Faron’s bexmarilimab
FDA grants orphan drug designation to Faron’s bexmarilimab
Pharmaceutical Business Review
Faron Pharmaceuticals
FDA
orphan drugs
bexmarilimab
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Galera earns key FDA designation for pancreatic cancer drug
Galera earns key FDA designation for pancreatic cancer drug
Clinical Trials Arena
Galera Therapeutics
pancreatic cancer
FDA
rucosopasem
orphan drugs
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SiSaf gets green light from FDA for osteopetrosis treatment
SiSaf gets green light from FDA for osteopetrosis treatment
Biopharma Reporter
SiSaf
orphan drugs
pediatric
FDA
osteopetrosis
SIS-101-ADO
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GSK receives orphan drug designation for Benlysta to treat systemic sclerosis
GSK receives orphan drug designation for Benlysta to treat systemic sclerosis
Pharmaceutical Business Review
GSK
FDA
orphan drugs
Benlysta
systemic sclerosis
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FDA restores orphan-exclusivity system after 18-month stall in wake of legal feud
FDA restores orphan-exclusivity system after 18-month stall in wake of legal feud
Medical Marketing and Media
FDA
orphan drugs
exclusivity
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Here Are the Top Five Biotech Trends for 2023
Here Are the Top Five Biotech Trends for 2023
NASDAQ
biotech
personalized medicine
bioprinting
tissue engineering
orphan drugs
drug discovery
gene editing
CRISPR
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FDA remains silent on orphan drug exclusivity after last year's court loss
FDA remains silent on orphan drug exclusivity after last year's court loss
Endpoints
FDA
orphan drug exclusivity
orphan drugs
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Intellia's CRISPR-engineered cell therapy secures FDA orphan drug status after AML trial launch
Intellia's CRISPR-engineered cell therapy secures FDA orphan drug status after AML trial launch
Fierce Biotech
Intellia Therapeutics
CRISPR
FDA
cell therapy
orphan drugs
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Biliary tract cancer drug granted orphan drug designation in US
Biliary tract cancer drug granted orphan drug designation in US
Pharmaforum
Senhwa
biliary tract cancer
silmitasertib
FDA
orphan drugs
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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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