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» priority review
priority review
UltraGenyx wins first drug approval, valuable PRV
BioPharma Dive
Thu, 11/16/17 - 07:17 pm
Ultragenyx
FDA
priority review
Mepsevii
Sly Syndrome
FDA Expands Generic Drug Priority Reviews
RAPS.org
Thu, 11/9/17 - 05:57 pm
FDA
generics
priority review
Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'
RAPS.org
Sun, 09/24/17 - 10:25 am
generics
FDA
priority review
Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.
Yahoo/Zacks.com
Sat, 08/26/17 - 07:41 pm
Vertex Pharmaceuticals
cystic fibrosis
FDA
priority review
EMA
tezacaftor/ivacaftor
Kalydeco
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
RAPS.org
Thu, 08/10/17 - 06:51 pm
drug approvals
FDA
priority review
accelerated approvals
fast track
breakthrough status
GSK uses priority voucher to file HIV combo
BioPharma Dive
Sat, 06/3/17 - 09:20 am
GSK
priority review
HIV
ViiV
Bayer cancer drug boards path to speedy approval at FDA
Fierce Biotech
Wed, 05/17/17 - 09:41 am
Bayer
FDA
copanlisib
priority review
non-Hodgkin's lymphoma
FDA Grants Priority Review For Amgen's BLINCYTO® (blinatumomab) Supplemental Biologics License Application
Yahoo
Wed, 03/29/17 - 05:01 pm
Amgen
FDA
priority review
Blincyto
acute lymphoblastic leukemia
Sarepta Sells Priority Review Voucher for $125M
Investopedia
Tue, 02/21/17 - 12:23 pm
Sarepta Therapeutics
Gilead Sciences
priority review
FDA
Pfizer shortens comeback campaign for armed antibody inotuzumab, lands quick FDA review
Endpoints
Tue, 02/21/17 - 11:34 am
Pfizer
inotuzumab ozogamicin
B cell acute lymphoblastic leukemia
priority review
FDA
Merck shares rise after hours on priority review lung cancer drug application
Marketwatch
Wed, 01/11/17 - 10:11 am
Merck
Keytruda
lung cancer
priority review
FDA
The FDA in 2016: By the numbers
Medical Marketing and Media
Wed, 01/4/17 - 10:52 am
FDA
drug approvals
priority review
breakthrough status
FDA Grants Merck Priority Review for Keytruda Drug (MRK)
Investopedia
Mon, 11/28/16 - 09:56 am
FDA
priority review
Keytruda
Merck
non-small cell lung cancer
anti-PD-L1
FDA accepts Merck & Co.'s Keytruda filing for first-line treatment of NSCLC, grants priority review
First Word Pharma
Wed, 09/7/16 - 10:13 am
Merck
FDA
Keytruda
non-small cell lung cancer
priority review
Clovis Jumps as Cancer Drug Gets Priority for FDA Review
Bloomberg
Tue, 08/23/16 - 05:47 pm
Clovis Oncology
FDA
priority review
rucaparib
ovarian cancer
Eisai scores FDA priority review for bigger Lenvima use in kidney cancer
Fierce Pharma
Wed, 01/20/16 - 08:40 am
Eisai
Lenvima
kidney cancer
FDA
priority review
Gilead gets FDA priority review of Hepatitis C combo drug
Marketwatch
Tue, 01/5/16 - 09:06 am
Gilead Sciences
FDA
priority review
hepatitis C
Sovaldi-velpatasir
Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer
Yahoo
Thu, 12/10/15 - 11:20 am
Pfizer
FDA
Ibrance
priority review
metastatic breast cancer
Bristol-Myers nabs FDA priority review for new Opdivo use in kidney cancer
Fierce Pharma
Tue, 11/17/15 - 05:57 pm
Bristol-Myers Squibb
FDA
priority review
Opdivo
kidney cancer
The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews
Fierce Biotech
Thu, 10/8/15 - 09:09 am
FDA
priority review
review vouchers
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