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accelerated approvals
What are Merck, Bristol Myers and Roche planning for the big FDA cancer approval review?
Fierce Pharma
Tue, 04/27/21 - 11:04 am
FDA
oncology
accelerated approvals
Merck
Keytruda
Bristol Myers Squibb
Opdivo
Roche
Tecentriq
FDA Advisory Committee to Review Checkpoint Inhibitors Greenlit Under Accelerated Approval
BioSpace
Sun, 04/25/21 - 01:56 pm
FDA
oncology
cancer
accelerated approvals
Bristol Myers Squibb
Opdivo
Roche
Tecentriq
Merck
Keytruda
MHRA kicks off new accelerated drug approval pathway with ‘innovation passports’
Endpoints
Mon, 04/5/21 - 02:49 pm
UK
MHRA
innovation
accelerated approvals
Go or no go? The FDA plays hardball
EP Vantage
Tue, 03/30/21 - 11:47 am
FDA
Pfizer
Roche
Merck
Bristol Myers Squibb
accelerated approvals
Industry-wide accelerated approval review yields four withdrawals
RAPS.org
Wed, 03/10/21 - 10:53 pm
FDA
Bristol-Meyers Squibb
Roche
Merck
AstraZeneca
accelerated approvals
Despite Imfinzi, US accelerated approvals surge
EP Vantage
Tue, 02/23/21 - 10:34 am
FDA
accelerated approvals
Imfinzi
AstraZeneca
Merck eats the lunch Bristol Myers never served, winning TMB-based OK for Keytruda
Endpoints
Wed, 06/17/20 - 10:48 am
Merck
Keytruda
Bristol-Myers Squibb
FDA
biomarkers
accelerated approvals
cancer
TMB
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
Wed, 06/17/20 - 10:46 am
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
FDA keeps the faith in surrogate endpoints
EP Vantage
Tue, 02/18/20 - 08:40 pm
FDA
surrogate endpoints
accelerated approvals
Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals
RAPS.org
Fri, 11/1/19 - 06:52 pm
Makena
FDA
preterm labor
accelerated approvals
One-Third of Pre-Approved Drugs Haven’t Completed FDA Approval Process
BioSpace
Wed, 08/28/19 - 10:41 pm
FDA
drug approvals
accelerated approvals
3 takeaways from cancer's biggest conference
Biopharma Dive
Thu, 06/6/19 - 10:03 pm
Amgen
KRAS
accelerated approvals
Turning Point Therapeutics
Keytruda
Opdivo
ASCO 2019
FDA should reassess postmarket trials for cancer drugs approved via accelerated pathway, researchers say
Endpoints
Wed, 05/29/19 - 10:22 am
FDA
cancer
postmarketing studies
accelerated approvals
FDA to Study DTC Ads for Drugs Approved Under Accelerated Process
RAPS.org
Tue, 05/7/19 - 11:52 am
FDA
DTC ads
accelerated approvals
AbbVie says not seeking accelerated approval for lung cancer drug
Yahoo/Reuters
Thu, 03/22/18 - 09:07 am
AbbVie
drug approvals
accelerated approvals
lung cancer
Rova-T
Accelerated Approval in Oncology: FDA Touts Successes, Responds to Criticism
RAPS.org
Mon, 03/5/18 - 02:58 pm
drug approvals
FDA
oncology
PMRs
accelerated approvals
Accelerating Accelerated Approval & Other Drug Development Signals from FDA’s Approval of 1st Therapy for Chagas
FDA Law Blog
Wed, 09/13/17 - 09:28 am
FDA
Chagas disease
Chemo Research
accelerated approvals
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
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