priority review

Pfizer spinout SpringWorks gets FDA priority review for lead drug
Pfizer spinout SpringWorks gets FDA priority review for lead drug
Endpoints
SpringWorks Therapeutics
Pfizer
nirogacestat
desmoid tumors
FDA
priority review
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Biogen, Sage Get FDA Priority Review of Zuranolone
Biogen, Sage Get FDA Priority Review of Zuranolone
Marketwatch
Biogen
SAGE Therapeutics
FDA
zuranolone
priority review
postpartum depression
major depressive disorder
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FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate
FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate
Endpoints
FDA
priority review
Pfizer
Prevnar 20
vaccines
Roche
bispecific antibodies
glofitamab
lymphoma
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Pfizer's RSV vaccine rush gets FDA boost with priority review
Pfizer's RSV vaccine rush gets FDA boost with priority review
Fierce Biotech
Pfizer
RSV
vaccines
FDA
priority review
RSVpreF
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FDA grants priority review for Daiichi Sankyo’s AML medicine
FDA grants priority review for Daiichi Sankyo’s AML medicine
Pharmaceutical Business Review
FDA
priority review
Daiichi Sankyo
quizartinib
acute myeloid leukemia
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Regeneron secures priority review for Eylea's use in infant retinopathy
Regeneron secures priority review for Eylea's use in infant retinopathy
Fierce Pharma
Eylea
Regeneron
retinopathy of prematurity
FDA
priority review
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After a rocky few months, Gilead's Trodelvy keeps recent winning streak rolling with priority review
After a rocky few months, Gilead's Trodelvy keeps recent winning streak rolling with priority review
Fierce Pharma
Gilead Sciences
breast cancer
Trodelvy
ESMO
FDA
priority review
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FDA to decide on Roche’s lymphoma drug Lunsumio before year-end
FDA to decide on Roche’s lymphoma drug Lunsumio before year-end
Pharmaforum
Roche
Lunsumio
follicular lymphoma
T-cell engager
FDA
priority review
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AbbVie Redeems Priority Review Voucher for Rinvoq Approval
AbbVie Redeems Priority Review Voucher for Rinvoq Approval
BioSpace
AbbVie
Rinvoq
priority review
priority review vouchers
ulcerative colitis
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CSL-UniQure Hemophilia B Gene Therapy Scores Priority Review
CSL-UniQure Hemophilia B Gene Therapy Scores Priority Review
BioSpace
CSL Behring
uniQure
hemophilia B
gene therapy
FDA
priority review
etranacogene dezaparvovec
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AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer
AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer
Pharmaforum
AstraZeneca
Imfinzi
biliary tract cancer
FDA
priority review
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Gilead collects 5th priority review voucher as public advocacy group urged the company to relinquish it
Gilead collects 5th priority review voucher as public advocacy group urged the company to relinquish it
Endpoints
Gilead Sciences
COVID-19
remdesivir
priority review
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After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA
After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA
Endpoints
AstraZeneca
FDA
tremelimumab
liver cancer
priority review
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Bristol Myers' Opdivo steps in FDA fast lane for potential first-in-class nod in pre-surgery lung cancer
Bristol Myers' Opdivo steps in FDA fast lane for potential first-in-class nod in pre-surgery lung cancer
Fierce Pharma
Bristol Myers Squibb
FDA
Opdivo
priority review
non-small cell lung cancer
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Bluebird bio may finally get a gene therapy approved in the US
Bluebird bio may finally get a gene therapy approved in the US
Endpoints
Bluebird Bio
gene therapy
FDA
Zynteglo
beta-thalassemia
priority review
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Boehringer-Lilly’s Jardiance obtains FDA priority review to treat heart failure
Boehringer-Lilly’s Jardiance obtains FDA priority review to treat heart failure
Pharmaceutical Business Review
Eli Lilly
Boehringer Ingelheim
Jardiance
priority review
FDA
heart failure
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Regeneron Antibody Cocktail a Priority for FDA with April Action Date
Regeneron Antibody Cocktail a Priority for FDA with April Action Date
BioSpace
Regeneron
FDA
priority review
COVID-19
antibodies
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Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too
Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too
Endpoints
Sanofi
FDA
sleeping sickness
fexinidazole
priority review
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FDA grants priority review for Pfizer COVID-19 vaccine BLA
FDA grants priority review for Pfizer COVID-19 vaccine BLA
Biopharma Reporter
Pfizer
BioNTech
COVID-19
vaccines
FDA
priority review
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MannKind and United Snag Priority Review for Pulmonary Hypertension Drug
MannKind and United Snag Priority Review for Pulmonary Hypertension Drug
BioSpace
MannKind
United Therapeutics
PAH
PH-ILD
FDA
priority review
Tyvaso
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