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accelerated approvals
FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence'
Fierce Biotech
Mon, 04/11/22 - 10:41 am
Robert Califf
FDA
accelerated approvals
regulatory
The FDA endorses accelerated approval reforms
Stat
Tue, 03/29/22 - 11:34 pm
FDA
accelerated approvals
congress
Accelerated approval reforms take center stage at House hearing, but a way forward remains unclear
Endpoints
Thu, 03/17/22 - 11:31 pm
accelerated approvals
FDA accelerated approvals targeted for revamp in House Energy and Commerce committee chair's new bill
Fierce Pharma
Tue, 03/8/22 - 10:11 am
FDA
accelerated approvals
Califf on accelerated approvals: Companies need to do more work before FDA says OK
Endpoints
Thu, 01/20/22 - 11:05 am
FDA
Robert Califf
accelerated approvals
Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending
RAPS.org
Mon, 12/6/21 - 11:44 pm
regulatory
accelerated approvals
Medicare
Accelerated approval reforms need meaningful confirmatory trial improvements, professors write in Science
Endpoints
Fri, 12/3/21 - 10:34 am
FDA
accelerated approvals
confirmatory trials
FDA cancels ODAC meeting this week to review two more dangling accelerated approvals — but won't explain why
Endpoints
Tue, 11/30/21 - 11:32 pm
FDA
ODAC
cancer
accelerated approvals
Secura Bio
Acrotech Biopharma
Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows
Endpoints
Tue, 11/9/21 - 11:46 pm
FDA
accelerated approvals
confirmatory trials
FDA's cancer drug advisors will review 2 more dangling accelerated approvals for multiple myeloma, leukemia
Endpoints
Thu, 09/23/21 - 10:34 pm
FDA
cancer
accelerated approvals
Secura Bio
Farydak
Multiple Myeloma
Acrotech Biopharma
Marqibo
FDA grants BeiGene's Brukinsa accelerated approval in marginal zone lymphoma
Seeking Alpha
Wed, 09/15/21 - 11:00 am
BeiGene
Brukinsa
FDA
accelerated approvals
marginal zone lymphoma
Study: 1/3 of Cancer Accelerated Approval Indications Remain Despite Lack of Confirmation
BioSpace
Mon, 09/13/21 - 11:31 pm
FDA
accelerated approvals
cancer
oncology
Rare disease drugmakers to Congress: Don't gut the accelerated approval pathway
Endpoints
Tue, 08/3/21 - 11:02 am
FDA
Rick Pazdur
accelerated approvals
Biogen
Aduhelm
US Congress
FDA, under pressure, plans ‘sprint’ to accelerate review of Pfizer’s Covid-19 vaccine for full approval
Stat
Sat, 07/31/21 - 10:16 pm
Pfizer
FDA
vaccines
COVID-19
accelerated approvals
Aduhelm’s accelerated approval offers a promising roadmap for rare neurological diseases
Stat
Wed, 07/7/21 - 10:36 pm
FDA
Biogen
Aduhelm
accelerated approvals
neurodegenerative disease
FDA and Biogen discussed Aduhelm's accelerated approval as early as 2019 — report
Endpoints
Tue, 06/29/21 - 11:05 am
FDA
Biogen
Aduhelm
accelerated approvals
Alzheimer's disease
DIA 2021 set to shed some light on decentralized trials process, accelerated approval pathways
Biopharma Reporter
Wed, 06/16/21 - 11:53 am
DIA
decentralized clinical trials
clinical trials
accelerated approvals
COVID-19
pandemic
These 3 Words From the FDA Ensure the Biogen Drama Is Far From Over
Motley Fool
Tue, 06/15/21 - 10:39 am
FDA
Biogen
Aduhelm
accelerated approvals
Alzheimer's disease
Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals
Endpoints
Thu, 04/29/21 - 10:55 pm
Merck
Roche
Bristol Myers Squibb
FDA
ODAC
accelerated approvals
Keytruda
Opdivo
Tecentriq
ODAC votes to keep Keytruda and Tecentriq accelerated approvals in bladder cancer
Endpoints
Wed, 04/28/21 - 10:12 pm
FDA
ODAC
accelerated approvals
Merck
Keytruda
Roche
Tecentriq
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