Emergency Use Authorization

FDA details plan to end emergency use authorizations for devices
FDA details plan to end emergency use authorizations for devices
Medtech Dive
devices
Medtech
FDA
COVID-19
Emergency Use Authorization
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FDA yanks EUA for AstraZeneca’s Evusheld as COVID variants continue to evolve
FDA yanks EUA for AstraZeneca’s Evusheld as COVID variants continue to evolve
Medical Marketing and Media
AstraZenenca
FDA
Evusheld
COVID-19
Emergency Use Authorization
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FDA narrows EUAs for Covid-19 tests, steering companies to traditional review pathways
FDA narrows EUAs for Covid-19 tests, steering companies to traditional review pathways
MedCity News
FDA
COVID-19
diagnostics
Emergency Use Authorization
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LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19
LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19
Medtech Dive
Medtech
diagnostics
COVID-19
Flu
RSV
FDA
LapCorp
Emergency Use Authorization
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Moderna to file for EUA of COVID-19 shot for very young kids by April end
Moderna to file for EUA of COVID-19 shot for very young kids by April end
Yahoo/Reuters
Moderna Therapeutics
COVID-19
vaccines
pediatric
Emergency Use Authorization
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FDA urges COVID-19 test makers with EUAs to seek full authorizations
FDA urges COVID-19 test makers with EUAs to seek full authorizations
Medtech Dive
diagnostics
FDA
COVID-19
Emergency Use Authorization
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Novavax finally submits its COVID-19 vaccine to the FDA. Is it too late?
Novavax finally submits its COVID-19 vaccine to the FDA. Is it too late?
Fierce Pharma
Novavax
COVID-19
vaccines
FDA
Emergency Use Authorization
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Novavax Stock Jumps As Drugmaker Looks to FDA Filing For Covid Vaccine By Year End
Novavax Stock Jumps As Drugmaker Looks to FDA Filing For Covid Vaccine By Year End
TheStreet.com
Novavax
vaccines
COVID-19
FDA
UAE
Emergency Use Authorization
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AstraZeneca's COVID therapy becomes first antibody approved for immunocompromised people preexposure
AstraZeneca's COVID therapy becomes first antibody approved for immunocompromised people preexposure
Fierce Pharma
AstraZeneca
COVID-19
antibodies
FDA
Emergency Use Authorization
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FDA expands emergency authorization for Covid-19 booster shots to all adults
FDA expands emergency authorization for Covid-19 booster shots to all adults
Stat
FDA
Moderna Therapeutics
Pfizer
BioNTech
vaccines
COVID-19
boosters
Emergency Use Authorization
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FDA clears Pfizer's Covid-19 vaccine for children ages 5-11
FDA clears Pfizer's Covid-19 vaccine for children ages 5-11
Endpoints
Pfizer
BioNTech
vaccines
COVID-19
FDA
Emergency Use Authorization
pediatric
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AstraZeneca files for FDA green light of COVID-preventing antibody
AstraZeneca files for FDA green light of COVID-preventing antibody
Fierce Biotech
AstraZeneca
COVID-19
antibodies
FDA
Emergency Use Authorization
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Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot
Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot
NY Times, NY
JNJ
vaccines
FDA
COVID-19
boosters
Emergency Use Authorization
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FDA authorizes Labcorp’s at-home test kit for Covid-19, flu
FDA authorizes Labcorp’s at-home test kit for Covid-19, flu
MedCity News
LapCorp
FDA
diagnostics
COVID-19
Flu
Emergency Use Authorization
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FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans
FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans
BioPharma Dive
FDA
Pfizer
COVID-19
boosters
Emergency Use Authorization
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FDA approves Eli Lilly antibody cocktail for COVID-19 prevention
FDA approves Eli Lilly antibody cocktail for COVID-19 prevention
Beckers Hospital Review
Eli Lilly
Emergency Use Authorization
COVID-19
antibodies
FDA
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FDA slams the door in Humanigen’s face, rejects emergency use green light, wants more data
FDA slams the door in Humanigen’s face, rejects emergency use green light, wants more data
Fierce Biotech
Humanigen
FDA
COVID-19
cytokine storm
Emergency Use Authorization
lenzilumab
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Mesoblast’s COVID-19 Respiratory Therapy Hits Another Snag on Route to Potential EUA
Mesoblast’s COVID-19 Respiratory Therapy Hits Another Snag on Route to Potential EUA
BioSpace
Mesoblast
COVID-19
Emergency Use Authorization
respiratory therapy
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Why Did the FDA Reject Rigel's EUA Application for Its COVID-19 Therapy?
Why Did the FDA Reject Rigel's EUA Application for Its COVID-19 Therapy?
Motley Fool
Rigel Pharmaceuticals
Emergency Use Authorization
FDA
Tavalisse
COVID-19
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Thermo Fisher Wins EUA for Next-Gen COVID-19 Test as Delta Rages On
Thermo Fisher Wins EUA for Next-Gen COVID-19 Test as Delta Rages On
Medical Devices and Diagnostics Industry
Thermo Fisher
TaqPath
COVID-19
diagnostics
FDA
Emergency Use Authorization
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