accelerated approvals

Despite Imfinzi, US accelerated approvals surge
Despite Imfinzi, US accelerated approvals surge
EP Vantage
FDA
accelerated approvals
Imfinzi
AstraZeneca
Flag link:
Merck eats the lunch Bristol Myers never served, winning TMB-based OK for Keytruda
Merck eats the lunch Bristol Myers never served, winning TMB-based OK for Keytruda
Endpoints
Merck
Keytruda
Bristol-Myers Squibb
FDA
biomarkers
accelerated approvals
cancer
TMB
Flag link:
Regulators discuss accelerated approvals, Project Orbis at DIA
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
Flag link:
FDA keeps the faith in surrogate endpoints
FDA keeps the faith in surrogate endpoints
EP Vantage
FDA
surrogate endpoints
accelerated approvals
Flag link:
Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals
Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals
RAPS.org
Makena
FDA
preterm labor
accelerated approvals
Flag link:
One-Third of Pre-Approved Drugs Haven’t Completed FDA Approval Process
One-Third of Pre-Approved Drugs Haven’t Completed FDA Approval Process
BioSpace
FDA
drug approvals
accelerated approvals
Flag link:
3 takeaways from cancer's biggest conference
3 takeaways from cancer's biggest conference
Biopharma Dive
Amgen
KRAS
accelerated approvals
Turning Point Therapeutics
Keytruda
Opdivo
ASCO 2019
Flag link:
FDA should reassess postmarket trials for cancer drugs approved via accelerated pathway, researchers say
FDA should reassess postmarket trials for cancer drugs approved via accelerated pathway, researchers say
Endpoints
FDA
cancer
postmarketing studies
accelerated approvals
Flag link:
FDA to Study DTC Ads for Drugs Approved Under Accelerated Process
FDA to Study DTC Ads for Drugs Approved Under Accelerated Process
RAPS.org
FDA
DTC ads
accelerated approvals
Flag link:
AbbVie says not seeking accelerated approval for lung cancer drug
AbbVie says not seeking accelerated approval for lung cancer drug
Yahoo/Reuters
AbbVie
drug approvals
accelerated approvals
lung cancer
Rova-T
Flag link:
Accelerated Approval in Oncology: FDA Touts Successes, Responds to Criticism
Accelerated Approval in Oncology: FDA Touts Successes, Responds to Criticism
RAPS.org
drug approvals
FDA
oncology
PMRs
accelerated approvals
Flag link:
Accelerating Accelerated Approval & Other Drug Development Signals from FDA’s Approval of 1st Therapy for Chagas
Accelerating Accelerated Approval & Other Drug Development Signals from FDA’s Approval of 1st Therapy for Chagas
FDA Law Blog
FDA
Chagas disease
Chemo Research
accelerated approvals
Flag link:
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
RAPS.org
drug approvals
FDA
priority review
accelerated approvals
fast track
breakthrough status
Flag link: