Aptitude Awarded Up to $54M BARDA Funding for At-Home Diagnostics
BARDA is partnering with Aptitude Medical Systems to accelerate development of two at-home molecular diagnostic tests for COVID-19 and influenza. ...
Tag: Emergency Use Authorization
Rapid COVID-19 PCR Test Developed at Northwestern Receives FDA Emergency Use Authorization
Northwestern University faculty and spinoff company developed the new technology A new highly sensitive, easy-to-use test for COVID-19 that requires ...
U.S. Purchases 600,000 Courses of Eli Lilly Monoclonal Antibody That Works Against Omicron
The U.S. Department of Health and Human Services (HHS) announced on Feb 10. it will acquire 600,000 treatment courses of ...
FDA Authorizes Flowflex COVID-19 Home Test from ACON Laboratories
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, ...
VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters
On Oct. 14 and 15, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the ...
OraSure Awarded $13.6M From BARDA to Advance COVID-19 Rapid Test
BARDA renews collaboration with OraSure Technologies to support InteliSwab™ COVID-19 Rapid Test 510(k) Clearance and CLIA Waiver BARDA and OraSure ...
What FDA Approval of Pfizer’s COVID-19 Vaccine Means for Unvaccinated People, Organizations and Pharma
The U.S. Food and Drug Administration approved the Pfizer-BioNTech coronavirus vaccine for use in people 16 and older on Aug. ...
What Does Full Approval of a Vaccine Do If It’s Already Authorized for Emergency Use?
Thirty percent of unvaccinated American adults say they’re waiting for the COVID-19 vaccines currently authorized for emergency use to be ...
COVID-19 Vaccine Boosters: Is a Third Dose Really Needed?
Around 85% of adults (44.8 million people) in the UK have received one vaccine dose and 63% (33 million people) ...
How Does the Johnson & Johnson Vaccine Compare to the Other Coronavirus Vaccines?
The U.S. Food and Drug Administration has authorized the use of the Johnson & Johnson coronavirus vaccine in adults. Maureen ...
Key Questions About South Africa’s Vaccine Rollout Plan
South Africa has recently started its COVID-19 vaccine roll-out. Around the country, frontline healthcare workers are getting a jab of ...
Watch: BARDA Director Talks About Emergency Use Authorization of Third COVID-19 Vaccine
Gary Disbrow, Ph.D., BARDA Director at HHS/ASPR, explains the public-private collaboration and platform technologies brought to bear for COVID-19 vaccines. ...
COVID-19 Vaccines Were Developed in Record Time – But are These Game-Changers Safe?
There are now two COVID-19 vaccines that, at least according to preliminary reports, appear to be 94.5% and 95% effective. ...
Pfizer and BioNTech Submit COVID-19 Vaccine for Emergency Use Approval in U.S.
Pfizer Inc. and BioNTech SE announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use ...
UCLA Scientists Pioneer SwabSeq Rapid COVID-19 Diagnostic
The U.S. Food and Drug Administration has granted emergency use authorization for scientists at UCLA Health to begin using a ...
Eli Lilly Says Antibody Combo Effective Against COVID, Asks for EUA
Eli Lilly and Company today announced additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy ...
FDA Grants EUA to DetectaChem for RT-LAMP Portable COVID-19 Diagnostic
The U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) on Sep. 1 to DetectaChem for the MobileDetect ...
Lessons From Hydroxychloroquine: Improving FDA’s Authorization and Approval Process
On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use ...
New Joint Venture from Mount Sinai Health System and Renalytix Will Scale Up Production of COVID Tests
Kantaro Biosciences, the new joint venture of Mount Sinai Health System and Renalytix AI, will develop and scale production of ...
FDA Issues Warning on Accuracy of Abbott ID NOW Coronavirus Test
The U.S. Food and Drug Administration issued an alert today about early data that suggests potential inaccurate results from using ...
