priority review

Merck snags priority review for Prevnar 13 rival — just one month after Pfizer sent its follow-on to the FDA
Merck snags priority review for Prevnar 13 rival — just one month after Pfizer sent its follow-on to the FDA
Endpoints
Merck
V114
pneumococcal disease
vaccines
FDA
priority review
Prevnar 13
Pfizer
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BridgeBio grabs a second priority review for the portfolio — giving Perceptive startup cause to celebrate
BridgeBio grabs a second priority review for the portfolio — giving Perceptive startup cause to celebrate
Endpoints
BridgeBio
priority review
QED Therapeutics
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FDA sets May date for verdict on ADC’s lymphoma drug Lonca
FDA sets May date for verdict on ADC’s lymphoma drug Lonca
Pharmaforum
ADC Therapeutics
Lonca
diffuse large B-cell lymphoma
FDA
priority review
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Watch out, Merck: FDA grants Regeneron, Sanofi's Libtayo priority review for coveted first-line use in lung cancer
Watch out, Merck: FDA grants Regeneron, Sanofi's Libtayo priority review for coveted first-line use in lung cancer
Fierce Pharma
Regeneron
Sanofi
Libtayo
FDA
priority review
non-small cell lung cancer
Merck
Keytruda
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Eyeing their first approval, BridgeBio sends their first drug to the FDA and lands a speedy review
Eyeing their first approval, BridgeBio sends their first drug to the FDA and lands a speedy review
Endpoints
BridgeBio
FDA
fosdenopterin
priority review
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FDA fast-tracks Leap’s gastric cancer immunotherapy
FDA fast-tracks Leap’s gastric cancer immunotherapy
Pharmaforum
Leap Therapeutics
FDA
DKN-01
priority review
gastric cancer
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FDA grants priority review to ide-cel, keeping Bristol Myers on track to deliver Celgene payday
FDA grants priority review to ide-cel, keeping Bristol Myers on track to deliver Celgene payday
Fierce Biotech
Bristol-Myers Squibb
Celgene
Bluebird Bio
FDA
priority review
ide-cel
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Biogen nabs speedy FDA review for controversial Alzheimer’s drug
Biogen nabs speedy FDA review for controversial Alzheimer’s drug
Fierce Biotech
Biogen
aducanumab
Eisai
FDA
Alzheimer's disease
priority review
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Looking at a groundbreaking advance, Myovant gets a priority review at FDA
Looking at a groundbreaking advance, Myovant gets a priority review at FDA
Endpoints
Myovant
FDA
priority review
Relugolix
prostate cancer
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Dicerna nabs speedy review voucher for leading RNAi drug
Dicerna nabs speedy review voucher for leading RNAi drug
Fierce Biotech
Dicerna
RNAi
priority review
nedosiran
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GSK's asthma drug Nucala gets speedy review for rare blood disorder
GSK's asthma drug Nucala gets speedy review for rare blood disorder
Endpoints
GSK
FDA
Nucala
hypereosinophilic syndrome
HES
priority review
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Sanofi nabs speedy review of sutimlimab, aiming for a November approval
Sanofi nabs speedy review of sutimlimab, aiming for a November approval
Fierce Biotech
Sanofi
cold agglutinin disease
sutimlimab
FDA
priority review
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BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings
BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings
Fierce Pharma
Bristol-Myers Squibb
Opdivo
Yervoy
non-small cell lung cancer
FDA
Europe
priority review
EMA
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Takeda’s ALUNBRIG gets FDA priority review for expanded indication in NSCLC
Takeda’s ALUNBRIG gets FDA priority review for expanded indication in NSCLC
Pharmaceutical Business Review
Takeda
Alunbrig
brigatinib
FDA
priority review
non-small cell lung cancer
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FDA Gives BioMarin Pharmaceuticals' Hemophilia Gene Therapy Priority Review
FDA Gives BioMarin Pharmaceuticals' Hemophilia Gene Therapy Priority Review
Motley Fool
FDA
Biomarin
priority review
valrox
gene therapy
hemophilia A
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FDA Grants Priority Review to Roche's Lung Cancer Drug Tecentriq
FDA Grants Priority Review to Roche's Lung Cancer Drug Tecentriq
Motley Fool
Roche
FDA
priority review
Tecentriq
non-squamous non-small cell lung cancer
non-small cell lung cancer
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Vifor buys priority review voucher for undisclosed filing
Vifor buys priority review voucher for undisclosed filing
Fierce Biotech
Vifor
priority review vouchers
FDA
priority review
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Jazz targets US launch of SCLC drug after FDA grants fast review
Jazz targets US launch of SCLC drug after FDA grants fast review
Pharmaforum
PharmaMar
Jazz Pharmaceuticals
FDA
small cell lung cancer
lurbinectedin
priority review
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Seattle Genetics' Experimental Breast Cancer Drug Receives Priority Review From the FDA
Seattle Genetics' Experimental Breast Cancer Drug Receives Priority Review From the FDA
Motley Fool
Seattle Genetics
tucatinib
FDA
priority review
breast cancer
HER-2 postive breast cancer
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Bristol-Myers' CAR-T gets priority review, mid-August PDUFA date
Bristol-Myers' CAR-T gets priority review, mid-August PDUFA date
Fierce Biotech
Bristol-Myers Squibb
FDA
lisocabtagene maraleucel
priority review
CAR-T
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