priority review

Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission
Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission
CP Wire
Pfizer
talazoparib
BRCA-mutant breast cancer
breast cancer
metastatic breast cancer
FDA
EMA
priority review
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Riding a wave of positive PhIII readouts, Pfizer gets a snap review for lung cancer drug dacomitinib
Riding a wave of positive PhIII readouts, Pfizer gets a snap review for lung cancer drug dacomitinib
Endpoints
Pfizer
priority review
FDA
lung cancer
dacomitinib
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UltraGenyx wins first drug approval, valuable PRV
UltraGenyx wins first drug approval, valuable PRV
BioPharma Dive
Ultragenyx
FDA
priority review
Mepsevii
Sly Syndrome
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FDA Expands Generic Drug Priority Reviews
FDA Expands Generic Drug Priority Reviews
RAPS.org
FDA
generics
priority review
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Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'
Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'
RAPS.org
generics
FDA
priority review
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Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.
Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.
Yahoo/Zacks.com
Vertex Pharmaceuticals
cystic fibrosis
FDA
priority review
EMA
tezacaftor/ivacaftor
Kalydeco
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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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GSK uses priority voucher to file HIV combo
GSK uses priority voucher to file HIV combo
BioPharma Dive
GSK
priority review
HIV
ViiV
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Bayer cancer drug boards path to speedy approval at FDA
Bayer cancer drug boards path to speedy approval at FDA
Fierce Biotech
Bayer
FDA
copanlisib
priority review
non-Hodgkin's lymphoma
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FDA Grants Priority Review For Amgen's BLINCYTO® (blinatumomab) Supplemental Biologics License Application
FDA Grants Priority Review For Amgen's BLINCYTO® (blinatumomab) Supplemental Biologics License Application
Yahoo
Amgen
FDA
priority review
Blincyto
acute lymphoblastic leukemia
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Sarepta Sells Priority Review Voucher for $125M
Sarepta Sells Priority Review Voucher for $125M
Investopedia
Sarepta Therapeutics
Gilead Sciences
priority review
FDA
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Pfizer shortens comeback campaign for armed antibody inotuzumab, lands quick FDA review
Pfizer shortens comeback campaign for armed antibody inotuzumab, lands quick FDA review
Endpoints
Pfizer
inotuzumab ozogamicin
B cell acute lymphoblastic leukemia
priority review
FDA
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Merck shares rise after hours on priority review lung cancer drug application
Merck shares rise after hours on priority review lung cancer drug application
Marketwatch
Merck
Keytruda
lung cancer
priority review
FDA
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The FDA in 2016: By the numbers
The FDA in 2016: By the numbers
Medical Marketing and Media
FDA
drug approvals
priority review
breakthrough status
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FDA Grants Merck Priority Review for Keytruda Drug (MRK)
FDA Grants Merck Priority Review for Keytruda Drug (MRK)
Investopedia
FDA
priority review
Keytruda
Merck
non-small cell lung cancer
anti-PD-L1
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FDA accepts Merck & Co.'s Keytruda filing for first-line treatment of NSCLC, grants priority review
FDA accepts Merck & Co.'s Keytruda filing for first-line treatment of NSCLC, grants priority review
First Word Pharma
Merck
FDA
Keytruda
non-small cell lung cancer
priority review
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Clovis Jumps as Cancer Drug Gets Priority for FDA Review
Clovis Jumps as Cancer Drug Gets Priority for FDA Review
Bloomberg
Clovis Oncology
FDA
priority review
rucaparib
ovarian cancer
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Eisai scores FDA priority review for bigger Lenvima use in kidney cancer
Eisai scores FDA priority review for bigger Lenvima use in kidney cancer
Fierce Pharma
Eisai
Lenvima
kidney cancer
FDA
priority review
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Gilead gets FDA priority review of Hepatitis C combo drug
Gilead gets FDA priority review of Hepatitis C combo drug
Marketwatch
Gilead Sciences
FDA
priority review
hepatitis C
Sovaldi-velpatasir
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Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer
Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer
Yahoo
Pfizer
FDA
Ibrance
priority review
metastatic breast cancer
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