priority review

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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
UltraGenyx wins first drug approval, valuable PRV
UltraGenyx wins first drug approval, valuable PRV
BioPharma Dive
Ultragenyx
FDA
priority review
Mepsevii
Sly Syndrome
Flag link:
FDA Expands Generic Drug Priority Reviews
FDA Expands Generic Drug Priority Reviews
RAPS.org
FDA
generics
priority review
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
GSK uses priority voucher to file HIV combo
GSK uses priority voucher to file HIV combo
BioPharma Dive
GSK
priority review
HIV
ViiV
Flag link:
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
Flag link:

Pages