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priority review
Regeneron Antibody Cocktail a Priority for FDA with April Action Date
BioSpace
Fri, 10/15/21 - 12:35 pm
Regeneron
FDA
priority review
COVID-19
antibodies
Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too
Endpoints
Wed, 07/21/21 - 11:07 am
Sanofi
FDA
sleeping sickness
fexinidazole
priority review
FDA grants priority review for Pfizer COVID-19 vaccine BLA
Biopharma Reporter
Mon, 07/19/21 - 10:59 am
Pfizer
BioNTech
COVID-19
vaccines
FDA
priority review
MannKind and United Snag Priority Review for Pulmonary Hypertension Drug
BioSpace
Wed, 06/16/21 - 11:17 pm
MannKind
United Therapeutics
PAH
PH-ILD
FDA
priority review
Tyvaso
Merck wins priority review for rare carcinoma drug belzutifan, the centerpiece of $1B+ Peloton buyout
Endpoints
Tue, 03/16/21 - 10:54 am
Merck
Peloton Therapeutics
belzutifan
M&A
PT2977
renal cell carcinoma
priority review
FDA
FDA delays Kadmon’s priority review as apparent clampdown continues
Endpoints
Thu, 03/11/21 - 10:40 am
Kadmon
FDA
priority review
belumodsil
graft vs host disease
FDA accepts priority review for Pfizer’s TicoVac
Pharmaceutical Business Review
Wed, 02/24/21 - 10:53 am
Pfizer
FDA
TicoVac
encephalitis
tick-borne encephalitis
priority review
Incyte Says FDA Grants Priority Review For Eczema Cream
Yahoo/SmarterAnalyst
Mon, 02/22/21 - 11:00 am
Incyte
eczema
FDA
priority review
ruxolitinib
Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug
Endpoints
Wed, 02/3/21 - 10:55 am
Bristol-Myers Squibb
Celgene
FDA
ulcerative colitis
priority review
Zeposia
Iterum nabs speedy FDA antibiotic review, but follows in the footsteps of bankrupt biotechs
Fierce Biotech
Tue, 01/26/21 - 11:16 am
Iterum
sulopenem
priority review
FDA
UTIs
antibiotics
Incyte lands priority review for PD-1 inhibitor in anal cancer
Fierce Biotech
Fri, 01/22/21 - 10:31 am
Incyte
FDA
priority review
anal cancer
retifanlimab
With patent concerns looming, Roche gets a new priority review on blockbuster IPF drug
Endpoints
Thu, 01/21/21 - 10:36 am
Roche
Esbriet
IPF
FDA
priority review
Merck snags priority review for Prevnar 13 rival — just one month after Pfizer sent its follow-on to the FDA
Endpoints
Tue, 01/12/21 - 10:59 am
Merck
V114
pneumococcal disease
vaccines
FDA
priority review
Prevnar 13
Pfizer
BridgeBio grabs a second priority review for the portfolio — giving Perceptive startup cause to celebrate
Endpoints
Tue, 12/1/20 - 12:18 pm
BridgeBio
priority review
QED Therapeutics
FDA sets May date for verdict on ADC’s lymphoma drug Lonca
Pharmaforum
Mon, 11/23/20 - 10:20 am
ADC Therapeutics
Lonca
diffuse large B-cell lymphoma
FDA
priority review
Watch out, Merck: FDA grants Regeneron, Sanofi's Libtayo priority review for coveted first-line use in lung cancer
Fierce Pharma
Thu, 10/29/20 - 12:17 pm
Regeneron
Sanofi
Libtayo
FDA
priority review
non-small cell lung cancer
Merck
Keytruda
Eyeing their first approval, BridgeBio sends their first drug to the FDA and lands a speedy review
Endpoints
Tue, 09/29/20 - 12:04 pm
BridgeBio
FDA
fosdenopterin
priority review
FDA fast-tracks Leap’s gastric cancer immunotherapy
Pharmaforum
Fri, 09/25/20 - 10:34 am
Leap Therapeutics
FDA
DKN-01
priority review
gastric cancer
FDA grants priority review to ide-cel, keeping Bristol Myers on track to deliver Celgene payday
Fierce Biotech
Tue, 09/22/20 - 12:18 pm
Bristol-Myers Squibb
Celgene
Bluebird Bio
FDA
priority review
ide-cel
Biogen nabs speedy FDA review for controversial Alzheimer’s drug
Fierce Biotech
Fri, 08/7/20 - 11:00 am
Biogen
aducanumab
Eisai
FDA
Alzheimer's disease
priority review
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