priority review

In starved antibiotic field, Melinta soars as FDA grants speedy drug review
In starved antibiotic field, Melinta soars as FDA grants speedy drug review
Endpoints
Melinta Therapeutics
antibiotics
Baxdela
community-acquired bacterial pneumonia
FDA
priority review
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J&J’s Invokana closes on diabetic kidney disease approval
J&J’s Invokana closes on diabetic kidney disease approval
Pharmaforum
FDA
JNJ
Invokana
diabetic kidney disease
kidney disease
priority review
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FDA tags Bayer's prostate cancer drug for priority review as drugmaker gears up against rivals
FDA tags Bayer's prostate cancer drug for priority review as drugmaker gears up against rivals
Endpoints
Bayer
Orion
prostate cancer
priority review
daralutamide
FDA
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Celgene gets fast FDA review of Revlimid combo in lymphoma
Celgene gets fast FDA review of Revlimid combo in lymphoma
Pharmaforum
Celgene
Revlimid
FDA
Roche
Rituxan
priority review
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AbbVie’s JAK inhibitor upadacitinib gets Priority Review
AbbVie’s JAK inhibitor upadacitinib gets Priority Review
Pharmaforum
AbbVie
upadacatinib
FDA
priority review
rheumatoid arthritis
Humira
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Keytruda-Inlyta combo under Priority Review for first-line RCC
Keytruda-Inlyta combo under Priority Review for first-line RCC
BioCentury
Merck
Keytruda
Inlyta
renal cell carcinoma
FDA
priority review
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Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
Biopharma Dive
Novartis
FDA
Egaten
fast pass
priority review
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FDA promises speedy review on moving Merck's Keytruda up as first-line head and neck cancer therapy
FDA promises speedy review on moving Merck's Keytruda up as first-line head and neck cancer therapy
Endpoints
Merck
Keytruda
FDA
head and neck cancer
priority review
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Daiichi gets speedy FDA review for rare cancer drug
Daiichi gets speedy FDA review for rare cancer drug
Pharmaforum
Daiichi Sankyo
FDA
pexidartinib
TGCT
priority review
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Heron's non-opioid HTX-011 gets Priority Review
Heron's non-opioid HTX-011 gets Priority Review
BioCentury
priority review
Heron Therapeutics
HTX-011
post-operative pain
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Novartis’ SMA Gene Therapy Is on the Fast Track for Approval
Novartis’ SMA Gene Therapy Is on the Fast Track for Approval
BioSpace
Novartis
gene therapy
SMA
AVXS-101
Zolgensma
priority review
FDA
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Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL
Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL
BioCentury
AbbVie
FDA
priority review
Imbruvica
Gazyva
CLL
SLL
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FDA Grants Priority Review to Keytruda Combination Therapy for Metastatic Squamous Non-Small Cell Lung Cancer
FDA Grants Priority Review to Keytruda Combination Therapy for Metastatic Squamous Non-Small Cell Lung Cancer
CP Wire
Merck
Keytruda
non-small cell lung cancer
metastatic squamous non-small cell lung cancer
priority review
FDA
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How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass
How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass
Biopharma Dive
Alexion
Soliris
fast pass
FDA
priority review
ALXN1210
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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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