accelerated approvals

Federal watchdog cites concerns with FDA’s accelerated approval process
BioPharma Dive
Wed, 01/15/25 - 11:48 pm
HHS
FDA
accelerated approvals
Aduhelm
Biogen
FDA looks to clarify confirmatory trial mandate for accelerated approvals
Fierce Pharma
Mon, 01/6/25 - 06:51 pm
FDA
regulatory
accelerated approvals
FDA’s Accelerated Approval of Sarepta DMD Gene Therapy Comes Under Fire
BioSpace
Fri, 05/3/24 - 11:20 am
FDA
accelerated approvals
Sarepta Therapeutics
DMD
gene therapy
AACR: Study Suggests Accelerated Approval Doesn’t Always Lead to Clinical Benefit
BioSpace
Wed, 04/10/24 - 05:44 pm
AACR
oncology
FDA
accelerated approvals
FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
Fierce Pharma
Wed, 11/15/23 - 11:20 am
FDA
regulatory
oncology
cancer
accelerated approvals
Acrotech Biopharma
Roche pulls a Gavreto approval before Blueprint severance, citing unfeasible trial
Fierce Pharma
Wed, 07/5/23 - 07:12 pm
Roche
Blueprint Medicines
cancer
Gavreto
accelerated approvals
FDA
The waxing and waning of the speedy approval
EP Vantage
Mon, 05/15/23 - 09:58 am
FDA
drug approvals
accelerated approvals
AbbVie
AstraZeneca
Bayer
Bristol Myers Squibb
JNJ
Merck
Merck KGaA
Novartis
Pfizer
Study: Half of confirmatory studies for accelerated approvals are late
RAPS.org
Tue, 04/4/23 - 11:20 pm
JAMA
regulatory
accelerated approvals
Proposed FDA guidelines to strengthen oversight on accelerated approval cancer drugs
Medical Marketing and Media
Mon, 03/27/23 - 09:57 pm
FDA
clinical trials
cancer
oncology
accelerated approvals
FDA has new leverage over companies looking for a quicker drug approval
NPR
Fri, 03/3/23 - 10:06 am
FDA
regulatory
accelerated approvals
drug approvals
Pharma wins changes in bill regarding FDA’s accelerated approval
Stat
Mon, 12/19/22 - 10:09 pm
legislation
regulatory
FDA
accelerated approvals
This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more
RAPS.org
Sun, 11/20/22 - 12:46 pm
FDA
Robert Califf
Richard Pazdur
accelerated approvals
Project Pragmatica
FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
RAPS.org
Fri, 11/18/22 - 10:32 am
FDA
cancer
oncology
accelerated approvals
Richard Pazdur
Federal watchdog highlights flaws in speedy FDA approvals
BioPharma Dive
Sun, 10/2/22 - 07:48 pm
FDA
regulatory
accelerated approvals
Study: Most accelerated approval indications don’t add high therapeutic value
RAPS.org
Sun, 08/21/22 - 09:45 pm
regulatory
accelerated approvals
Europe
FDA
Sarepta shares buoyed by pledge to seek an early swift review for Duchenne gene therapy
Fierce Biotech
Fri, 07/29/22 - 10:20 am
Sarepta Therapeutics
SRP-9001
Duchenne Muscular Dystrophy
Roche
accelerated approvals
Drugmakers are slow to prove medicines that got a fast track to market really work
NPR
Sun, 07/24/22 - 07:52 pm
FDA
drug approvals
accelerated approvals
fast track
cancer
FDA chief says US has 'got to do better' at generating medical product data
Fierce Biotech
Wed, 07/13/22 - 08:24 pm
FDA
accelerated approvals
Robert Califf
BIO research outlines risks in changing accelerated approval pathway
Biopharma Reporter
Tue, 06/21/22 - 12:04 pm
BIO Conference
FDA
drug approvals
accelerated approvals
US House Votes to Give FDA More Power Over Accelerated Approvals
BioSpace
Sun, 06/12/22 - 08:21 pm
FDA
regulatory
accelerated approvals
legislation

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