Emergency Use Authorization

FDA authorizes first home self-testing kit for COVID-19
Biopharma Reporter
Wed, 11/18/20 - 12:08 pm
FDA
COVID-19
diagnostics
Emergency Use Authorization
Lucira
Pfizer May File for Emergency Authorization of Coronavirus Vaccine Within the Week
Motley Fool
Tue, 11/17/20 - 11:24 pm
Pfizer
Emergency Use Authorization
vaccines
COVID-19
BioNTech
Data on emergency approval of COVID-19 drugs, vaccines to be made public
Beckers Hospital Review
Tue, 11/17/20 - 11:08 pm
COVID-19
vaccines
Emergency Use Authorization
FDA
transparency
Woodcock: Pharma, regulators have lessons to learn from COVID
RAPS.org
Thu, 11/12/20 - 11:07 pm
Janet Woodcock
pandemic
COVID-19
clinical trials
Emergency Use Authorization
Regeneron posts second look on Covid-19 antibody cocktail, boosting its case for EUA — but what about symptom alleviation?
Endpoints
Thu, 10/29/20 - 12:04 pm
Regeneron
COVID-19
antibodies
FDA
Emergency Use Authorization
[video + transcript]What's the Timeline for FDA Emergency Use Authorization of Coronavirus Vaccines?
Motley Fool
Sat, 10/24/20 - 11:31 pm
FDA
Pfizer
BioNTech
vaccines
COVID-19
Emergency Use Authorization
FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines
Stat
Fri, 10/23/20 - 11:00 am
FDA
COVID-19
vaccines
expanded access programs
Emergency Use Authorization
Moderna CEO Says COVID-19 Vaccine Could Get Emergency Approval in December
BioSpace
Wed, 10/21/20 - 11:48 pm
Moderna Therapeutics
vaccines
COVID-19
FDA
Emergency Use Authorization
Stephane Bancel
Pfizer CEO Anticipates EUA for COVID-19 Vaccine in Late November
BioSpace
Mon, 10/19/20 - 10:59 am
Pfizer
Albert Bourla
Emergency Use Authorization
BioNTech
vaccines
COVID-19
clinical trials
FDA reissues Chinese respirator EUA, but freezes new additions
RAPS.org
Sun, 10/18/20 - 08:36 pm
FDA
China
devices
Emergency Use Authorization
COVID-19
Pfizer to apply for COVID-19 vaccine EUA after mid-November safety data milestone
Biopharma Reporter
Fri, 10/16/20 - 11:18 am
Pfizer
Emergency Use Authorization
COVID-19
Albert Bourla
8 Important Medtech Updates from FDA
Medical Devices and Diagnostics Industry
Thu, 10/15/20 - 12:21 pm
devices
Medtech
pandemic
FDA
Emergency Use Authorization
digital health
quality
patients
ISO 13485
Roche to launch high-volume SARS-CoV-2 antigen test
Biopharma Reporter
Tue, 10/13/20 - 11:05 am
Roche
COVID-19
Elecsys
diagnostics
FDA
CE Mark
Emergency Use Authorization
Abbott’s Fast and Furious Pace with COVID-19-Related Tests Continues
Medical Devices and Diagnostics Industry
Mon, 10/12/20 - 05:57 pm
Abbott Labs
diagnostics
COVID-19
AdviseDx
Emergency Use Authorization
FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs
RAPS.org
Thu, 10/8/20 - 11:24 pm
FDA
COVID-19
Emergency Use Authorization
laboratory developed tests
LDTs
Regeneron submits request for EUA for COVID-19 antibody cocktail
Biopharma Reporter
Thu, 10/8/20 - 11:12 am
Regeneron
antibodies
COVID-19
Donald Trump
Emergency Use Authorization
Regeneron Shares Jump On FDA Hopes After Trump Receives Its Experimental COVID-19 Treatment
TheStreet.com
Mon, 10/5/20 - 10:54 am
Regeneron
Emergency Use Authorization
FDA
COVID-19
Donald Trump
Under fire, FDA to issue stricter guidance for Covid-19 vaccine EUA this week — report
Endpoints
Wed, 09/23/20 - 10:31 am
FDA
vaccines
COVID-19
Emergency Use Authorization
Medicare May Not Cover Cost of Coronavirus Vaccine
Motley Fool
Mon, 09/21/20 - 11:57 pm
Medicare
vaccines
COVID-19
Emergency Use Authorization
Verily Achieves Another Milestone in Battle Against COVID-19
Medical Devices and Diagnostics Industry
Wed, 09/9/20 - 08:10 pm
Verily
diagnostics
FDA
Emergency Use Authorization
pooled testing
COVID-19

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