Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older
On Jan. 3, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
FDA authorized COVID-19 Over-the-Counter test based on data from NIH Independent Test Assessment Program
On Dec. 27, 2021, the U.S. Food and Drug Administration authorized an over-the-counter (OTC) COVID-19 antigen test, the…
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COVID-19 heroes & Remembrance
Our Heroes and Remembrance illustration has Maurice Ralph Hilleman and John Enders, pioneering developers of common vaccines, and…
Biotechnology | COVID-19 | FDA | Medicine | Pharmaceutical | Therapeutics
Merck and Ridgeback’s molnupiravir received U.S. FDA EUA for treatment of high-risk adults with COVID-19
On Dec. 23, 2021, Merck and Ridgeback Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) had…
Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment
On Dec. 22, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
CytoDyn submited protocol with FDA for phase 3 Registrational trial of leronlimab for critically ill COVID-19 population
On Dec. 9, 2021, CytoDyn announced that it had submitted a Phase 3, randomized, double blind, placebo controlled…
Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 16 years and older
On Dec. 9, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
Roche announced the launch SARS-CoV-2 & Flu A/B Rapid Antigen Test in countries accepting the CE Mark
On Dec. 5, 2021, Roche announced that its planned to launch the SARS-CoV-2 & Flu A/B Rapid Antigen…
SIGA announced Health Canada regulatory approval of Oral TPOXX
On Dec. 1, 2021, SIGA Technologies announced that Health Canada had approved oral TPOXX (tecovirimat) as an extraordinary…
INOVIO Announced Strategy to Address Omicron (B.1.1.529) and Future SARS-CoV-2 Variants
On Nov. 30, 2021, Inovio Pharma announced the company was rapidly moving to evaluate its COVID-19 DNA vaccine…
Johnson & Johnson COVID-19 vaccine fully approved by Health Canada to prevent COVID-19 in ages 18 years and older
On Nov. 24, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued Emergency…
FDA authorized InBios COVID-19 over-the-counter antigen test
On Nov. 22, 2021, the U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) COVID-19 antigen test. The…
Pfizer and BioNTech received expanded U.S. FDA EUA of COVID-19 vaccine booster to include individuals 18 and older
On Nov. 19, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
FDA announced FDA authorization of Moderna’s booster dose of COVID-19 vaccine in the U.S. for adults 18 years and older
On Nov. 19, 2021, the U.S. Food and Drug Administration (FDA) announced that it had extended the emergency…
Pfizer provided U.S. Government with 10 million treatment courses of oral antiviral candidate to help combat COVID-19
On Nov. 18, 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses…
Zosano Pharma announced successful formulation of COVID-19 vaccine candidate on its microneedle patch system
On Nov. 17, 2021, Zosano Pharma announced that the Philippine Food and Drug Administration had granted emergency use…
Biotechnology | COVID-19 | FDA | Therapeutics | Vaccine
GSK and Vir Biotechnology announced U.S. government agreements to purchase sotrovimab, a COVID-19 treatment
On Nov. 17, 2021, GlaxoSmithKline and Vir Biotechnology announced U.S. government contracts totalling approximately $1 billion (USD) to…
Pfizer submitted Emergency Use Authorization for novel COVID-19 oral antiviral candidate
On Nov. 16, 2021, Pfizer announced it had submitted an Emergency Use Authorization (EUA) of its investigational oral…
Innovation Pharmaceuticals announced topline results from phase 2 clinical trial of brilacidin for COVID-19
On Nov. 11, 2021, Innovation Pharma reported topline results from the Companyﾒs Phase 2 clinical trial of Brilacidin…
Meridian Bioscience received FDA Emergency Use Authorization for Revogeneﾮ SARS-CoV-2 molecular assay
On Nov. 10, 2021, Meridian Bioscience announced that their Revogeneﾮ SARS-CoV-2 assay was granted Emergency Use Authorization by…
Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization…
INOVIO received FDA authorization to proceed with INNOVATE phase 3 segment for COVID-19 vaccine candidate
On Nov. 9, 2021, Inovio Pharma announced that the U.S. Food and Drug Administration (FDA) provided authorization to…
FDA authorized additional indication for BinaxNOW COVID-19 over-the-counter antigen test
On Nov. 8, 2021, The U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for…
The FDA issued an emergency use authorization for the iHealth COVID-19 Antigen Rapid Test
On Nov. 5, 2021, the U.S. Food and Drug Administration The FDA issued an emergency use authorization (EUA)…
U.S. FDA authorizd InteliSwabﾙ COVID-19 rapid tests for at-home testing for delta variant detection
On Nov. 2, 2021, OraSure Technologies announced that the EUA for its InteliSwabﾙ COVID-19 rapid tests had been…
FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2
On Nov. 1, 2021, the U.S. Food and Drug Administration (FDA) cleared the first 510(k) for a COVID-19…
Moderna updated timing of U.S. Emergency Use Authorization of its COVID-19 vaccine for adolescents
On Oct. 31, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had notified the Company…
Pfizer and BioNTech received first U.S. FDA EUA of COVID-19 vaccine in children ages 5 through 11 years
On Oct. 29, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had authorized…
FDA Advisory Committee votes in favor of granting EUA for Pfizer-BioNTech Covid-19 vaccine in children 5 to <12 years
On Oct. 26, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administrationﾒs (FDA) Vaccines and…
Moderna announced positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age
On Oct. 25, 2021, Moderna announced positive interim data from the Phase 2/3 study, called the KidCOVE study,…