Moderna submited amendment to EUA for an additional booster dose of its COVID-19 vaccine in the U.S.
On Mar. 17, 2022, Moderna announced that it had submitted a request to the U.S. Food and Drug…
FDA made low-risk determination for marketing of products from genome-edited beef cattle after safety review
On Mar. 7, 2022, the U.S. Food and Drug Administration announced it had made a low-risk determination for…
Sorrento announced FDA authorization to proceed with phase 1 study of Intranasal STI-9199 against Covid-19 viruses
On Mar. 2, 2022, Sorrento Therapeutics announced that it had received clearance from the FDA for its investigational…
Pfizer and BioNTech updated rolling submission for EUA of COVID-19 caccine in children 6 months through 4 years of Age
On Feb. 11, 2022, Pfizer and BioNTech announced plans to extend their rolling submission to the U.S. Food…
Pfizer and BioNTech initiated rolling submission for EUA of COVID-19 vaccine in children 6 months through 4 years of age
On Feb. 1, 2022, Pfizer and BioNTech announced that following a request from the U.S. Food and Drug…
Moderna received full U.S. FDA approval for COVID-19 vaccine Spikevax
On Jan. 31, 2022, Moderna announced the U.S. Food and Drug Administration (FDA)Â had approved the Biologics License…
Novavax submitted request to U.S. FDA for Emergency Use Authorization of COVID-19 vaccine
On Jan. 31, 2022, Novavax announced that it had submitted a request to the U.S Food and Drug…
InteliSwabï¾® COVID-19 rapid tests receive U.S. FDA authorization for pediatric use
On Jan. 31, 2022, OraSure Technologies announced that its InteliSwabï¾® COVID-19 rapid tests had been authorized by the…
Veru announced FDA Grant of Fast Track Designation for Sabizabulin for treatment of hospitalized COVID-19 patients
On Jan. 31, 2022, Veru announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…
COVID-19 | FDA | Life Science History | NIH
Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenic
On Jan. 26, 2022, the NIH announced that adults who had previously received a full regimen of any…
FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression
On Jan. 20, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration had granted expedited approval…
South Korea Ministry of Food and Drug Safety approved Novavax COVID-19 vaccine
On Jan. 12, 2022, Novavax and SK bioscience, a vaccine business subsidiary of Korea-based SK Group, announced that…
BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants
On Jan. 11, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19
On Jan. 10, 2022, Novartis Molecular Partners announced that Part A of the EMPATHY clinical trial that compared…
COVID-19 | FDA | Life Science History | NIH
NRx Pharmac submited EUA Application to US FDA for ZYESAMIï¾® (aviptadil) to treat patients at risk of death from COVID-19
On Jan 5, 2022, NRx Pharmaceuticals announced that it had submitted an application for Emergency Use Authorization (EUA)…
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…
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…
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 authorized another over-the-counter (OTC) COVID-19 antigen test. The…
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 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…
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…