FDA

FDA Advisory Committee Votes Unanimously in Favor of Expanding Amarin’s Vascepa Label
FDA Advisory Committee Votes Unanimously in Favor of Expanding Amarin’s Vascepa Label
RAPS.org
FDA
advisory panel
Amarin
Vascepa
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Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes
Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes
RAPS.org
FDA
JAMA
infectious diseases
drug development
surrogate endpoints
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FDA slaps a hold on an AML trial as Marker scraps a failing ovarian cancer program, sinking shares
FDA slaps a hold on an AML trial as Marker scraps a failing ovarian cancer program, sinking shares
Endpoints
Marker Therapeutics
AML
ovarian cancer
clinical trials
FDA
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China's BeiGene gets FDA approval for drug to treat rare form of lymphoma
China's BeiGene gets FDA approval for drug to treat rare form of lymphoma
Yahoo/Reuters
BeiGene
China
FDA
Brukinsa
mantle cell lymphoma
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FDA Panel Votes Against Lilly's Jardiance for Type I Diabetes
FDA Panel Votes Against Lilly's Jardiance for Type I Diabetes
Zacks.com
Eli Lilly
Boehringer Ingelheim
FDA
Jardiance
type 1 diabetes
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FDA still allowing secret reports on medical devices
FDA still allowing secret reports on medical devices
Star Tribune, MN
devices
patient safety
FDA
transparency
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FDA grants breakthrough status to AI-based gastric cancer diagnostic
FDA grants breakthrough status to AI-based gastric cancer diagnostic
Medtech Dive
gastric cancer
AI Medical Service
diagnostics
FDA
artificial intelligence
devices
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Supernus Pharmaceuticals seeks FDA approval for ADHD drug
Supernus Pharmaceuticals seeks FDA approval for ADHD drug
Bizjournals
ADHD
FDA
Supernus Pharmaceuticals
SPN-812
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AstraZeneca plans 2020 filing for anifrolumab in lupus
AstraZeneca plans 2020 filing for anifrolumab in lupus
Fierce Biotech
AstraZeneca
FDA
lupus
anifrolumab
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Shares of Amarin rise on favorable opinion from FDA committee
Shares of Amarin rise on favorable opinion from FDA committee
Marketwatch
FDA
Amarin
Vascepa
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Solid Biosciences’ Duchenne gene therapy trial halted after patient suffers serious toxicity
Solid Biosciences’ Duchenne gene therapy trial halted after patient suffers serious toxicity
Stat
Solid Biosciences
Duchenne Muscular Dystrophy
clinical trials
gene therapy
FDA
SGT-001
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FDA rejects Lipocine's testosterone drug for third time
FDA rejects Lipocine's testosterone drug for third time
Reuters
FDA
Lipocine
low testosterone
Tlando
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Breakthrough status and promise of a speedy review arrives for Opdivo/Yervoy combination as Bristol-Myers bites at Bayer
Breakthrough status and promise of a speedy review arrives for Opdivo/Yervoy combination as Bristol-Myers bites at Bayer
Endpoints
Bristol-Myers Squibb
Opdivo
liver cancer
Yervoy
FDA
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Regenxbio sues FDA over gene therapy clinical hold
Regenxbio sues FDA over gene therapy clinical hold
Fierce Biotech
Regenxbio
FDA
clinical hold
gene therapy
clinical trials
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FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
RAPS.org
FDA
orphan drugs
Indivior
Sublocade
opioid use disorder
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Sarepta Therapeutics CEO playing nice with FDA over rejection of Duchenne drug
Sarepta Therapeutics CEO playing nice with FDA over rejection of Duchenne drug
Stat
Sarepta Therapeutics
Doug Ingram
FDA
Vyondys 53
Duchenne Muscular Dystrophy
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Best Practices for Postmarket Drug Safety Surveillance: FDA Seeks Comments
Best Practices for Postmarket Drug Safety Surveillance: FDA Seeks Comments
RAPS.org
FDA
post-marketing data
patient safety
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FDA Gives Nod for Breakthrough HIV Test
FDA Gives Nod for Breakthrough HIV Test
Medical Devices and Diagnostics Industry
Vela Diagnostics
HIV
diagnostics
FDA
Sentosa SQ HIV Genotyping Assay
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Meet the Next FDA Commissioner: Stephen Hahn
Meet the Next FDA Commissioner: Stephen Hahn
Xtalks
FDA
Stephen Hahn
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Sanofi’s Fluzone quadrivalent formulation gets FDA nod in older people
Sanofi’s Fluzone quadrivalent formulation gets FDA nod in older people
Pharmaceutical Business Review
Sanofi
Fluzone Quadrivalent
vaccines
FDA
influenza
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