FDA

Nearly 300 gene and cell therapies in development – report
Nearly 300 gene and cell therapies in development – report
Pharmaforum
gene therapy
cell therapy
FDA
PhRMA
drug development
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FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
RAPS.org
FDA
real world evidence
real world data
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FDA breaks NME approval record in 2018
FDA breaks NME approval record in 2018
BioCentury
FDA
drug approvals
NMEs
new molecular entity
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Tecentriq could be first front-line SCLC therapy approved in two decades
Tecentriq could be first front-line SCLC therapy approved in two decades
BioCentury
FDA
Tecentriq
Genentech
extensive-stage small cell lung cancer
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Pops Diabetes wins FDA clearance for blood glucose monitoring system
Pops Diabetes wins FDA clearance for blood glucose monitoring system
Mass Device
Pops Diabetes Care
FDA
blood glucose monitoring
mobile apps
devices
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Biosimilar makers back Pfizer in call to end misleading brand marketing
Biosimilar makers back Pfizer in call to end misleading brand marketing
BioCentury
FDA
Pfizer
biosimilars
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In a first, FDA recognizes genetic database, removing regulatory hurdle
In a first, FDA recognizes genetic database, removing regulatory hurdle
BioCentury
FDA
genetic database
ClinGen Expert Curate Human Genetic Data
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FDA Wants to Change the De Novo Pathway
FDA Wants to Change the De Novo Pathway
Medical Devices and Diagnostics Industry
FDA
devices
de novo pathway
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Novartis’ SMA Gene Therapy Is on the Fast Track for Approval
Novartis’ SMA Gene Therapy Is on the Fast Track for Approval
BioSpace
Novartis
gene therapy
SMA
AVXS-101
Zolgensma
priority review
FDA
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FDA Issues Draft Guidance on NASH Drug Development
FDA Issues Draft Guidance on NASH Drug Development
RAPS.org
FDA
NASH
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FDA chooses 8 medtech companies for opioid crisis challenge
FDA chooses 8 medtech companies for opioid crisis challenge
Mass Device
FDA
devices
opioids
opioid crisis
Algomet Rx
Avanos
Brainsway
CognifiSense
iPill
Masimo
Milliman
ThermoTek
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Adaptive Trial Designs: BIO, Janssen, ACRO Call for Tweaks to FDA Draft Guidance
Adaptive Trial Designs: BIO, Janssen, ACRO Call for Tweaks to FDA Draft Guidance
RAPS.org
clinial trials
adaptive trial design
FDA
BIO
ACRO
Janssen
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FDA Faulted For Lapses In Orphan Drug Program
FDA Faulted For Lapses In Orphan Drug Program
NPR
FDA
orphan drugs
Rare Diseases
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Off-the-shelf cell therapy for cancer? Fate Therapeutics to make its case at ASH
Off-the-shelf cell therapy for cancer? Fate Therapeutics to make its case at ASH
Fierce Biotech
Fate Therapeutics
FDA
FT500
solid tumors
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FDA signs off on Editas CRISPR study on patients with a rare genetic disorder
FDA signs off on Editas CRISPR study on patients with a rare genetic disorder
Stat
CRISPR
Editas Medicine
FDA
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Theravance Pipeline Strong, Plans Yupelri Launch by Year End
Theravance Pipeline Strong, Plans Yupelri Launch by Year End
Yahoo/Zacks.com
Theravance
FDA
Yupelri
COPD
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FDA hits Sanofi's struggling Lemtrada with new safety warning over reports of stroke, artery tears
FDA hits Sanofi's struggling Lemtrada with new safety warning over reports of stroke, artery tears
Fierce Pharma
Sanofi
Lemtrada
FDA
stroke
MS
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FDA to Follow EMA With Move From London to Amsterdam
FDA to Follow EMA With Move From London to Amsterdam
RAPS.org
FDA
Amsterdam
EMA
Europe
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First Device Cleared for the Prevention of Cluster Headache
First Device Cleared for the Prevention of Cluster Headache
Medical Devices and Diagnostics Industry
cluster headaches
devices
vagus nerve stimulation
FDA
electroCore
gammaCore
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Alkermes Schizophrenia Drug Heads To FDA, But Questions Linger
Alkermes Schizophrenia Drug Heads To FDA, But Questions Linger
Xconomy
ALKS-3831
Alkermes
schizophrenia
FDA
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