fast track

Signaling a major shift at the FDA, regulators put Amicus’ once-spurned drug on fast track
Signaling a major shift at the FDA, regulators put Amicus’ once-spurned drug on fast track
Endpoints
FDA
Amicus Therapeutics
migalastat
Fabry disease
fast track
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Sanofi, Regeneron earn ‘breakthrough’ status for a fast-track drug out to prove PD-1 dominance
Sanofi, Regeneron earn ‘breakthrough’ status for a fast-track drug out to prove PD-1 dominance
Endpoints
Sanofi
Regeneron
fast track
breakthrough status
cemiplimab
anti-PD-L1
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Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
RAPS.org
drug approvals
FDA
priority review
accelerated approvals
fast track
breakthrough status
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OncoSec wins fast track designation for electroporation combo therapy
OncoSec wins fast track designation for electroporation combo therapy
Drug Delivery Business News
OncoSec
fast track
FDA
electroporation
ImmunoPulse IL-12
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Bristol-Myers shares drop after company says it will not seek fast-track drug approval
Bristol-Myers shares drop after company says it will not seek fast-track drug approval
CNBC
Bristol-Myers Squibb
fast track
lung cancer
Opdivo
Yervoy
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Biogen Inc to Surge on FDA Win of Alzheimer’s Drug
Biogen Inc to Surge on FDA Win of Alzheimer’s Drug
Bidness, ETC
Biogen
Alzheimer's disease
FDA
fast track
aducanumab
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Lilly and AstraZeneca Receive FDA Fast Track Designation for AZD3293, an Investigational Treatment for Early Alzheimer's Disease
Lilly and AstraZeneca Receive FDA Fast Track Designation for AZD3293, an Investigational Treatment for Early Alzheimer's Disease
Yahoo
Eli Lilly
AstraZeneca
AZD3293
fast track
FDA
Alzheimer's disease
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Ariad Taking The Fast Track Into Lung Cancer Treatment
Ariad Taking The Fast Track Into Lung Cancer Treatment
Seeking Alpha
Ariad Pharmaceuticals
fast track
non-small cell lung cancer
Ponatinib
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Oxigene Receives Fast Track Designation From U.S. FDA for CA4P
Oxigene Receives Fast Track Designation From U.S. FDA for CA4P
Yahoo
Oxigene
fast track
FDA
CA4P
ovarian cancer
platinum-resistant ovarian cancer
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FDA fast-tracks Omeros' kidney drug as company moves into Phase 3 tests
FDA fast-tracks Omeros' kidney drug as company moves into Phase 3 tests
Bizjournals.com
FDA
fast track
Omeros
OMS721
kidney disease
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FDA Fast Track Designation Granted to Luspatercept for the Treatment of Patients with Lower-Risk Myelodysplastic Syndromes
FDA Fast Track Designation Granted to Luspatercept for the Treatment of Patients with Lower-Risk Myelodysplastic Syndromes
Yahoo
FDA
fast track
luspatercept
myelodysplastic syndromes
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AstraZeneca wins big with fast FDA OK of AZD9291 for lung cancer
AstraZeneca wins big with fast FDA OK of AZD9291 for lung cancer
Fierce Biotech
AstraZeneca
FDA
fast track
AZD9291
lung cancer
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Corbus Wins With FDA Fast Track Designation
Corbus Wins With FDA Fast Track Designation
Yahoo/24-7 Wall St
Corbus
FDA
fast track
Resunab
cystic fibrosis
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Drug companies are paying huge sums to fast-track FDA approval
Drug companies are paying huge sums to fast-track FDA approval
Fortune
fast track
FDA
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FDA Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer
FDA Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer
Yahoo
Can-Fite BioPharma
CF102
FDA
fast track
hepatocellular carcinoma
liver cancer
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Roche haemophilia drug wins fast-track FDA designation
Roche haemophilia drug wins fast-track FDA designation
Yahoo/Reuters
Roche
Genentech
FDA
fast track
hemophilia A
ACE910
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Corbus' shares soar on FDA news that could speed up drug approval
Corbus' shares soar on FDA news that could speed up drug approval
Bizjournals.com
Resunab
Corbus Pharmaceuticals
FDA
fast track
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A pair of Celgene partners gets on the FDA fast track
A pair of Celgene partners gets on the FDA fast track
Fierce Biotech
Celgene
FDA
fast track
luspatercept
Acceleron
beta-thalassemia
AG-120
Agios Pharmaceuticals
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Merck KGaA, Threshold win fast track for pancreatic cancer drug
Merck KGaA, Threshold win fast track for pancreatic cancer drug
Yahoo/Reuters
Merck KGaA
Threshold Pharmaceuticals
pancreatic cancer
FDA
fast track
evofosfamide
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AstraZeneca scores fast-track FDA review for big new Brilinta use
AstraZeneca scores fast-track FDA review for big new Brilinta use
Fierce Pharma
AstraZeneca
FDA
fast track
Brilinta
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