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» priority review
priority review
Merck’s Keytruda gets FDA priority review for high-risk NMIBC
Pharmaceutical Business Review
Mon, 12/2/19 - 10:46 am
Merck
Keytruda
bladder cancer
priority review
NMIBC
FDA
FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarcinoma
Pharmaceutical Business Review
Fri, 11/29/19 - 02:24 pm
FDA
Incyte
priority review
pemigatinib
cholangiocarcinoma
Horizon secures FDA priority review for teprotumumab for treatment of active thyroid eye disease
Pharmaceutical Business Review
Tue, 09/10/19 - 09:41 am
Horizon Therapeutics
FDA
teprotumumab
thyroid eye disease
priority review
Pfizer, Astellas rocket toward broader Xtandi use with FDA 'priority' tag
Fierce Pharma
Thu, 08/22/19 - 11:56 am
Pfizer
Astellas
Xtandi
prostate cancer
FDA
priority review
Everything Old is New Again: FDA Revises its 2014 Rare Pediatric Disease Priority Review Voucher Guidance for Industry
FDA Law Blog
Fri, 08/2/19 - 12:17 am
FDA
priority review
priority review vouchers
pediatric
In starved antibiotic field, Melinta soars as FDA grants speedy drug review
Endpoints
Thu, 06/20/19 - 09:53 am
Melinta Therapeutics
antibiotics
Baxdela
community-acquired bacterial pneumonia
FDA
priority review
J&J’s Invokana closes on diabetic kidney disease approval
Pharmaforum
Thu, 05/23/19 - 09:50 am
FDA
JNJ
Invokana
diabetic kidney disease
kidney disease
priority review
FDA tags Bayer's prostate cancer drug for priority review as drugmaker gears up against rivals
Endpoints
Mon, 04/29/19 - 12:02 pm
Bayer
Orion
prostate cancer
priority review
daralutamide
FDA
Celgene gets fast FDA review of Revlimid combo in lymphoma
Pharmaforum
Wed, 02/27/19 - 10:49 am
Celgene
Revlimid
FDA
Roche
Rituxan
priority review
AbbVie’s JAK inhibitor upadacitinib gets Priority Review
Pharmaforum
Wed, 02/20/19 - 11:23 am
AbbVie
upadacatinib
FDA
priority review
rheumatoid arthritis
Humira
Keytruda-Inlyta combo under Priority Review for first-line RCC
BioCentury
Fri, 02/15/19 - 10:34 am
Merck
Keytruda
Inlyta
renal cell carcinoma
FDA
priority review
Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
Biopharma Dive
Thu, 02/14/19 - 05:43 pm
Novartis
FDA
Egaten
fast pass
priority review
FDA promises speedy review on moving Merck's Keytruda up as first-line head and neck cancer therapy
Endpoints
Mon, 02/11/19 - 10:24 am
Merck
Keytruda
FDA
head and neck cancer
priority review
Daiichi gets speedy FDA review for rare cancer drug
Pharmaforum
Fri, 02/8/19 - 09:38 am
Daiichi Sankyo
FDA
pexidartinib
TGCT
priority review
Heron's non-opioid HTX-011 gets Priority Review
BioCentury
Wed, 01/2/19 - 06:49 pm
priority review
Heron Therapeutics
HTX-011
post-operative pain
Novartis’ SMA Gene Therapy Is on the Fast Track for Approval
BioSpace
Mon, 12/3/18 - 05:55 pm
Novartis
gene therapy
SMA
AVXS-101
Zolgensma
priority review
FDA
Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL
BioCentury
Wed, 10/17/18 - 12:24 pm
AbbVie
FDA
priority review
Imbruvica
Gazyva
CLL
SLL
FDA Grants Priority Review to Keytruda Combination Therapy for Metastatic Squamous Non-Small Cell Lung Cancer
CP Wire
Mon, 07/2/18 - 09:21 am
Merck
Keytruda
non-small cell lung cancer
metastatic squamous non-small cell lung cancer
priority review
FDA
How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass
Biopharma Dive
Tue, 06/19/18 - 09:40 pm
Alexion
Soliris
fast pass
FDA
priority review
ALXN1210
Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission
CP Wire
Thu, 06/7/18 - 12:07 pm
Pfizer
talazoparib
BRCA-mutant breast cancer
breast cancer
metastatic breast cancer
FDA
EMA
priority review
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