priority review

FDA grants priority review for AstraZeneca’s Calquence sNDA
Pharmaceutical Business Review
Fri, 10/4/24 - 09:26 am
AstraZeneca
Calquence
FDA
priority review
Novartis touts surrogate endpoint win, nabs priority review for Fabhalta in IgAN
Fierce Pharma
Mon, 04/15/24 - 09:32 pm
Novartis
Fabhalta
IgAN
priority review
FDA
Sanofi, Regeneron Secure FDA Priority Review for Dupixent in COPD
BioSpace
Fri, 02/23/24 - 10:43 am
FDA
Sanofi
Regeneron
Dupixent
priority review
COPD
Ipsen/Genfit eye June FDA verdict for liver drug elafibranor
Pharmaphorum
Thu, 12/7/23 - 11:01 am
Genfit
Ipsen
elafibranor
primary biliary cholangitis
FDA
priority review
FDA starts review of Padcev/Keytruda for bladder cancer
Pharmaphorum
Fri, 12/1/23 - 09:35 am
Merck
Astellas
Seagen
Padcev
bladder cancer
FDA
priority review
Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag
Yahoo/Zacks.com
Thu, 09/21/23 - 06:32 pm
Merck
Keytruda
FDA
cervical cancer
priority review
Pfizer spinout SpringWorks gets FDA priority review for lead drug
Endpoints
Mon, 02/27/23 - 10:14 am
SpringWorks Therapeutics
Pfizer
nirogacestat
desmoid tumors
FDA
priority review
Biogen, Sage Get FDA Priority Review of Zuranolone
Marketwatch
Mon, 02/6/23 - 10:47 am
Biogen
SAGE Therapeutics
FDA
zuranolone
priority review
postpartum depression
major depressive disorder
FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate
Endpoints
Sun, 01/8/23 - 09:59 pm
FDA
priority review
Pfizer
Prevnar 20
vaccines
Roche
bispecific antibodies
glofitamab
lymphoma
Pfizer's RSV vaccine rush gets FDA boost with priority review
Fierce Biotech
Wed, 12/7/22 - 11:45 pm
Pfizer
RSV
vaccines
FDA
priority review
RSVpreF
FDA grants priority review for Daiichi Sankyo’s AML medicine
Pharmaceutical Business Review
Tue, 10/25/22 - 10:37 am
FDA
priority review
Daiichi Sankyo
quizartinib
acute myeloid leukemia
Regeneron secures priority review for Eylea's use in infant retinopathy
Fierce Pharma
Wed, 10/12/22 - 11:40 pm
Eylea
Regeneron
retinopathy of prematurity
FDA
priority review
After a rocky few months, Gilead's Trodelvy keeps recent winning streak rolling with priority review
Fierce Pharma
Tue, 10/11/22 - 04:08 pm
Gilead Sciences
breast cancer
Trodelvy
ESMO
FDA
priority review
FDA to decide on Roche’s lymphoma drug Lunsumio before year-end
Pharmaforum
Wed, 07/6/22 - 10:49 am
Roche
Lunsumio
follicular lymphoma
T-cell engager
FDA
priority review
AbbVie Redeems Priority Review Voucher for Rinvoq Approval
BioSpace
Thu, 06/23/22 - 07:53 pm
AbbVie
Rinvoq
priority review
priority review vouchers
ulcerative colitis
CSL-UniQure Hemophilia B Gene Therapy Scores Priority Review
BioSpace
Tue, 05/24/22 - 04:34 pm
CSL Behring
uniQure
hemophilia B
gene therapy
FDA
priority review
etranacogene dezaparvovec
AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer
Pharmaforum
Thu, 05/5/22 - 10:38 am
AstraZeneca
Imfinzi
biliary tract cancer
FDA
priority review
Gilead collects 5th priority review voucher as public advocacy group urged the company to relinquish it
Endpoints
Tue, 05/3/22 - 10:49 am
Gilead Sciences
COVID-19
remdesivir
priority review
After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA
Endpoints
Mon, 04/25/22 - 10:20 am
AstraZeneca
FDA
tremelimumab
liver cancer
priority review
Bristol Myers' Opdivo steps in FDA fast lane for potential first-in-class nod in pre-surgery lung cancer
Fierce Pharma
Mon, 02/28/22 - 11:32 am
Bristol Myers Squibb
FDA
Opdivo
priority review
non-small cell lung cancer

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