FDA

Rare Disease Clinical Trials: FDA Awards $15M in Grants
Rare Disease Clinical Trials: FDA Awards $15M in Grants
RAPS.org
grants
clinical trials
FDA
Rare Diseases
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FDA leaders worry agency will lose out on talent in gene therapy, cancer fields
FDA leaders worry agency will lose out on talent in gene therapy, cancer fields
Biopharma Dive
FDA
gene therapy
oncology
cell therapy
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Novartis’ new eye drug undercuts Bayer’s rival with fewer injections
Novartis’ new eye drug undercuts Bayer’s rival with fewer injections
Pharmaforum
Novartis
brolucizumab
Bayer
Eylea
wet age-related macular degeneration
FDA
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Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
Stat
Makena
premature birth
Amag Pharmaceuticals
FDA
citizen petitions
Public Citizen
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Is FDA Becoming Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss
Is FDA Becoming Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss
RAPS.org
FDA
drug approvals
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Novartis' latest Zolgensma data bode well for use in older patients
Novartis' latest Zolgensma data bode well for use in older patients
Fierce Pharma
Novartis
Zolgensma
SMA
FDA
spinal muscular atrophy
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DBV Technologies announces FDA acceptance of BLA filing for Viaskin Peanut to treat peanut allergy
DBV Technologies announces FDA acceptance of BLA filing for Viaskin Peanut to treat peanut allergy
Pharmaceutical Business Review
Viaskin Peanut
DBV Technologies
FDA
peanut allergy
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FDA approves Pfenex's osteoporosis therapy
FDA approves Pfenex's osteoporosis therapy
Yahoo/Reuters
Pfenex
osteoporosis
PF708
FDA
Eli Lilly
Forteo
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Update on FDA Approvals for 2019
Update on FDA Approvals for 2019
Eye on FDA
FDA
drug approvals
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FDA green lights AstraZeneca's asthma drug Fasenra for self-administration
FDA green lights AstraZeneca's asthma drug Fasenra for self-administration
Yahoo/Reuters
AstraZeneca
FDA
asthma
Fasenra
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Gilead scores PrEP approval for Descovy — kicking off marketing push before Truvada generics swarm
Gilead scores PrEP approval for Descovy — kicking off marketing push before Truvada generics swarm
Endpoints
Gilead Sciences
Descovy
HIV
PrEP
FDA
Truvada
generics
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What the Cybersecurity Alert Really Means for Device Manufacturers
What the Cybersecurity Alert Really Means for Device Manufacturers
Xtalks
FDA
devices
cybersecurity
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J&J seeks wider use of its Spravato antidepressant in US
J&J seeks wider use of its Spravato antidepressant in US
Pharmaforum
JNJ
FDA
Spravato
suicide
antidepressants
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Distorted Drug Patents: Does the U.S. Legal System Steer Researchers Away From Drugs that Take a Long Time to Develop?
Distorted Drug Patents: Does the U.S. Legal System Steer Researchers Away From Drugs that Take a Long Time to Develop?
FDA Law Blog
patents
innovation
drug development
FDA
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FDA to Further Investigate Implantable Devices Containing Certain Metals
FDA to Further Investigate Implantable Devices Containing Certain Metals
RAPS.org
FDA
devices
implants
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Sarepta competitor files with FDA for Duchenne drug
Sarepta competitor files with FDA for Duchenne drug
Seeking Alpha
Sarepta Therapeutics
NS Pharma
golodirsen
FDA
Duchenne Muscular Dystrophy
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FDA Warns of Widespread Device Cyber Vulnerabilities
FDA Warns of Widespread Device Cyber Vulnerabilities
RAPS.org
FDA
devices
cybersecurity
hacking
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Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process
Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process
Stat
FDA
Stephen Hahn
Donald Trump
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AstraZeneca's combo lung disease therapy fails to win FDA approval
AstraZeneca's combo lung disease therapy fails to win FDA approval
Reuters
AstraZeneca
FDA
COPD
PT010
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Alphabet taps former FDA commissioner to oversee health strategy and policy
Alphabet taps former FDA commissioner to oversee health strategy and policy
CNBC
Alphabet
FDA
Robert Califf
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