accelerated approvals

Roche pulls a Gavreto approval before Blueprint severance, citing unfeasible trial
Roche pulls a Gavreto approval before Blueprint severance, citing unfeasible trial
Fierce Pharma
Roche
Blueprint Medicines
cancer
Gavreto
accelerated approvals
FDA
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The waxing and waning of the speedy approval
The waxing and waning of the speedy approval
EP Vantage
FDA
drug approvals
accelerated approvals
AbbVie
AstraZeneca
Bayer
Bristol Myers Squibb
JNJ
Merck
Merck KGaA
Novartis
Pfizer
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Study: Half of confirmatory studies for accelerated approvals are late
Study: Half of confirmatory studies for accelerated approvals are late
RAPS.org
JAMA
regulatory
accelerated approvals
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Proposed FDA guidelines to strengthen oversight on accelerated approval cancer drugs
Proposed FDA guidelines to strengthen oversight on accelerated approval cancer drugs
Medical Marketing and Media
FDA
clinical trials
cancer
oncology
accelerated approvals
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FDA has new leverage over companies looking for a quicker drug approval
FDA has new leverage over companies looking for a quicker drug approval
NPR
FDA
regulatory
accelerated approvals
drug approvals
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Pharma wins changes in bill regarding FDA’s accelerated approval
Pharma wins changes in bill regarding FDA’s accelerated approval
Stat
legislation
regulatory
FDA
accelerated approvals
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This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more
This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more
RAPS.org
FDA
Robert Califf
Richard Pazdur
accelerated approvals
Project Pragmatica
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FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
RAPS.org
FDA
cancer
oncology
accelerated approvals
Richard Pazdur
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Federal watchdog highlights flaws in speedy FDA approvals
Federal watchdog highlights flaws in speedy FDA approvals
BioPharma Dive
FDA
regulatory
accelerated approvals
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Study: Most accelerated approval indications don’t add high therapeutic value
Study: Most accelerated approval indications don’t add high therapeutic value
RAPS.org
regulatory
accelerated approvals
Europe
FDA
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Sarepta shares buoyed by pledge to seek an early swift review for Duchenne gene therapy
Sarepta shares buoyed by pledge to seek an early swift review for Duchenne gene therapy
Fierce Biotech
Sarepta Therapeutics
SRP-9001
Duchenne Muscular Dystrophy
Roche
accelerated approvals
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Drugmakers are slow to prove medicines that got a fast track to market really work
Drugmakers are slow to prove medicines that got a fast track to market really work
NPR
FDA
drug approvals
accelerated approvals
fast track
cancer
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FDA chief says US has 'got to do better' at generating medical product data
FDA chief says US has 'got to do better' at generating medical product data
Fierce Biotech
FDA
accelerated approvals
Robert Califf
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BIO research outlines risks in changing accelerated approval pathway
BIO research outlines risks in changing accelerated approval pathway
Biopharma Reporter
BIO Conference
FDA
drug approvals
accelerated approvals
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US House Votes to Give FDA More Power Over Accelerated Approvals
US House Votes to Give FDA More Power Over Accelerated Approvals
BioSpace
FDA
regulatory
accelerated approvals
legislation
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FDA plots multi-day hearing to review 'dangling' accelerated approval that drugmaker refuses to pull
FDA plots multi-day hearing to review 'dangling' accelerated approval that drugmaker refuses to pull
Endpoints
FDA
accelerated approvals
Covis Pharma
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Is biopharma getting better at accelerated approval conversions?
Is biopharma getting better at accelerated approval conversions?
EP Vantage
FDA
CDER
accelerated approvals
regulatory
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CMS official on Alzheimer's drug coverage decision: Don't read between the lines for other accelerated approvals
CMS official on Alzheimer's drug coverage decision: Don't read between the lines for other accelerated approvals
Endpoints
CMS
Medicare
Biogen
Aduhelm
accelerated approvals
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FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence'
FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence'
Fierce Biotech
Robert Califf
FDA
accelerated approvals
regulatory
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The FDA endorses accelerated approval reforms
The FDA endorses accelerated approval reforms
Stat
FDA
accelerated approvals
congress
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