Emergency Use Authorization

Regeneron posts second look on Covid-19 antibody cocktail, boosting its case for EUA — but what about symptom alleviation?
Regeneron posts second look on Covid-19 antibody cocktail, boosting its case for EUA — but what about symptom alleviation?
Endpoints
Regeneron
COVID-19
antibodies
FDA
Emergency Use Authorization
Flag link:
[video + transcript]What's the Timeline for FDA Emergency Use Authorization of Coronavirus Vaccines?
[video + transcript]What's the Timeline for FDA Emergency Use Authorization of Coronavirus Vaccines?
Motley Fool
FDA
Pfizer
BioNTech
vaccines
COVID-19
Emergency Use Authorization
Flag link:
FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines
FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines
Stat
FDA
COVID-19
vaccines
expanded access programs
Emergency Use Authorization
Flag link:
Moderna CEO Says COVID-19 Vaccine Could Get Emergency Approval in December
Moderna CEO Says COVID-19 Vaccine Could Get Emergency Approval in December
BioSpace
Moderna Therapeutics
vaccines
COVID-19
FDA
Emergency Use Authorization
Stephane Bancel
Flag link:
Pfizer CEO Anticipates EUA for COVID-19 Vaccine in Late November
Pfizer CEO Anticipates EUA for COVID-19 Vaccine in Late November
BioSpace
Pfizer
Albert Bourla
Emergency Use Authorization
BioNTech
vaccines
COVID-19
clinical trials
Flag link:
FDA reissues Chinese respirator EUA, but freezes new additions
FDA reissues Chinese respirator EUA, but freezes new additions
RAPS.org
FDA
China
devices
Emergency Use Authorization
COVID-19
Flag link:
Pfizer to apply for COVID-19 vaccine EUA after mid-November safety data milestone
Pfizer to apply for COVID-19 vaccine EUA after mid-November safety data milestone
Biopharma Reporter
Pfizer
Emergency Use Authorization
COVID-19
Albert Bourla
Flag link:
8 Important Medtech Updates from FDA
8 Important Medtech Updates from FDA
Medical Devices and Diagnostics Industry
devices
Medtech
pandemic
FDA
Emergency Use Authorization
digital health
quality
patients
ISO 13485
Flag link:
Roche to launch high-volume SARS-CoV-2 antigen test
Roche to launch high-volume SARS-CoV-2 antigen test
Biopharma Reporter
Roche
COVID-19
Elecsys
diagnostics
FDA
CE Mark
Emergency Use Authorization
Flag link:
Abbott’s Fast and Furious Pace with COVID-19-Related Tests Continues
Abbott’s Fast and Furious Pace with COVID-19-Related Tests Continues
Medical Devices and Diagnostics Industry
Abbott Labs
diagnostics
COVID-19
AdviseDx
Emergency Use Authorization
Flag link:
FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs
FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs
RAPS.org
FDA
COVID-19
Emergency Use Authorization
laboratory developed tests
LDTs
Flag link:
Regeneron submits request for EUA for COVID-19 antibody cocktail
Regeneron submits request for EUA for COVID-19 antibody cocktail
Biopharma Reporter
Regeneron
antibodies
COVID-19
Donald Trump
Emergency Use Authorization
Flag link:
Regeneron Shares Jump On FDA Hopes After Trump Receives Its Experimental COVID-19 Treatment
Regeneron Shares Jump On FDA Hopes After Trump Receives Its Experimental COVID-19 Treatment
TheStreet.com
Regeneron
Emergency Use Authorization
FDA
COVID-19
Donald Trump
Flag link:
Under fire, FDA to issue stricter guidance for Covid-19 vaccine EUA this week — report
Under fire, FDA to issue stricter guidance for Covid-19 vaccine EUA this week — report
Endpoints
FDA
vaccines
COVID-19
Emergency Use Authorization
Flag link:
Medicare May Not Cover Cost of Coronavirus Vaccine
Medicare May Not Cover Cost of Coronavirus Vaccine
Motley Fool
Medicare
vaccines
COVID-19
Emergency Use Authorization
Flag link:
Verily Achieves Another Milestone in Battle Against COVID-19
Verily Achieves Another Milestone in Battle Against COVID-19
Medical Devices and Diagnostics Industry
Verily
diagnostics
FDA
Emergency Use Authorization
pooled testing
COVID-19
Flag link:
Roche to launch 40M rapid coronavirus antigen tests per month, starting in Europe
Roche to launch 40M rapid coronavirus antigen tests per month, starting in Europe
Fierce Biotech
Roche
COVID-19
diagnostics
Europe
FDA
Emergency Use Authorization
Flag link:
FDA Willing to Authorize Coronavirus Vaccine Before Phase 3 Trials Are Complete, Agency Head Says
FDA Willing to Authorize Coronavirus Vaccine Before Phase 3 Trials Are Complete, Agency Head Says
Motley Fool
FDA
vaccines
COVID-19
Stephen Hahn
clinical trials
Emergency Use Authorization
Flag link:
FDA extends remdesivir's emergency use authorization to all hospitalized COVID-19 patients
FDA extends remdesivir's emergency use authorization to all hospitalized COVID-19 patients
Beckers Hospital Review
FDA
Gilead Sciences
remdesivir
COVID-19
Emergency Use Authorization
Flag link:
Why Novavax's Coronavirus Vaccine Might Be First to Market
Why Novavax's Coronavirus Vaccine Might Be First to Market
Motley Fool
FDA
Novavax
JNJ
Moderna Therapeutics
AstraZeneca
vaccines
COVID-19
clinical trials
Emergency Use Authorization
Flag link:

Pages