Tag: Accelerated approval

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Recent Related Articles to Accelerated approval

Alzheimer's breakthrough signals game changer for biotech sector

Added to Collection on: 2021-06-30 09:00:00

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Life Sciences
Health sciences
Food and Drug Administration
Health
Pharmaceutical industry
Breakthrough therapy
Biogen
Aducanumab
Center for Drug Evaluation and Research
Alzheimer's disease
Accelerated approval
Clinical trial

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Otsuka wins FDA breakthrough therapy designation for IgAN drug

Added to Collection on: 2024-02-16 18:07:35

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Kidney diseases
IgA nephropathy
Kidney disease
Igan
Accelerated approval
Breakthrough therapy
Fabry disease
Sanofi

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Larimar Therapeutics Advances Nomlabofusp Clinical Program with First Patient Dosed in ...

Added to Collection on: 2024-03-16 20:15:23

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Food and Drug Administration
Frataxin
Proteins
Friedreich's ataxia
Ataxin
Clinical trial
Accelerated approval
Larimar Therapeutics Inc.

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With Duchenne decision ahead, FDA's Marks pushes for speedy gene therapy approvals

Added to Collection on: 2024-05-24 20:16:31

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Biotechnology
Food and Drug Administration
Corvallis, Oregon
Sarepta Therapeutics
Duchenne muscular dystrophy
Gene therapy
Delandistrogene moxeparvovec
Accelerated approval
Peter Marks

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Vigil Neuroscience Inc: Caution Advised Amid FDA Openness to Accelerated Approval and ...

Added to Collection on: 2024-07-18 19:59:34

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Nervous system
Neurology
Neurophysiology
Neuroscience
Accelerated approval
Sanofi
Microglia
vigil neuroscience
Vigil Neuroscience Inc.

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Vigil Neuroscience Inc: Promising Drug Development and Potential for Accelerated FDA ...

Added to Collection on: 2024-07-19 18:18:27

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Biomarkers
Alzheimer's disease
TREM2
Neuroscience
Accelerated approval
Andrew Fein
vigil neuroscience
Vigil Neuroscience Inc.

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Deep Dive: FDA's Accelerated Approval Pathway Under Fire - BioSpace

Added to Collection on: 2024-12-16 19:52:20

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Food and Drug Administration
Biotechnology
Accelerated approval
Drug development
Orphan drugs
Aducanumab
Surrogate endpoint
Biogen
Gene therapy
Duchenne muscular dystrophy
Voxelotor
Delandistrogene moxeparvovec

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Makary's 'Conditional Approval' Pathway for Rare Diseases Poses More Questions Than Answers

Added to Collection on: 2025-05-19 04:07:47

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Drug discovery
Food and Drug Administration
Clinical research
Design of experiments
Accelerated approval
Drug development
Ultragenyx
Aducanumab
Sarepta Therapeutics
Emil Kakkis
Marty Makary
Orphan drug
Vinay Prasad

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Biogen's Felzartamab in PMN: A Pioneering Play in Rare Kidney Disease Therapeutics

Added to Collection on: 2025-06-30 14:22:27

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Kidney diseases
Biogen
IgA nephropathy
Membranous glomerulonephritis
Accelerated approval
Kidney transplantation
Nephrology
Tacrolimus
Orphan drug
Nephrotic syndrome
Proteinuria
Kidney disease

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Intercept Pharmaceuticals Withdraws Ocaliva from Shelves Following U.S. Regulator's Request

Added to Collection on: 2025-09-11 17:55:16

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Orphan drugs
Bile acids
Cholanes
Hepatology
Autoimmune diseases
Obeticholic acid
Intercept Pharmaceuticals
Primary biliary cholangitis
Ursodeoxycholic acid
Food and Drug Administration
Accelerated approval
Clinical trial
United States

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