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» breakthrough status
breakthrough status
Roche scores an unusual ‘breakthrough’ at the FDA for an autism drug
Endpoints
Mon, 01/29/18 - 09:22 am
Roche
FDA
breakthrough status
autism
RG7314
balovaptan
FDA adds ‘breakthrough’ status for Alnylam as patisiran starts its victory lap at the agency
Endpoints
Mon, 11/20/17 - 07:45 pm
FDA
Alnylam
Patisiran
breakthrough status
Sanofi, Regeneron earn ‘breakthrough’ status for a fast-track drug out to prove PD-1 dominance
Endpoints
Fri, 09/8/17 - 09:38 am
Sanofi
Regeneron
fast track
breakthrough status
cemiplimab
anti-PD-L1
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
Pfizer wins a “breakthrough” title for ALK/ROS1 contender lorlatinib after hustling into PhIII
Endpoints
Thu, 04/27/17 - 05:49 pm
Pfizer
breakthrough status
lorlatinib
metastatic non-small cell lung cancer
Novartis Snags Coveted FDA 'Breakthrough' Label for CAR-T, Trial Results Still Under Wraps
TheStreet.com
Tue, 04/18/17 - 09:49 am
Novartis
Kite Pharma
FDA
CAR-T
breakthrough status
CTL019
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
Novartis-backed Gamida Cell grabs a breakthrough trophy for experimental cell treatment
Endpoints
Tue, 10/11/16 - 09:25 pm
Gamida Cell
Novartis
NiCord
bone marrow transplants
breakthrough status
Novartis' blood cancer drug bags a 'breakthrough' tag on the way to FDA filing
Fierce Biotech
Fri, 02/19/16 - 11:10 am
Novartis
blood cancer
breakthrough status
PKC412
FDA
AstraZeneca wins FDA breakthrough status for key cancer drug
Yahoo/Reuters
Wed, 02/17/16 - 10:32 am
AstraZeneca
FDA
breakthrough status
durvalumab
bladder cancer
anti-PD-L1
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