Moderna completed submission of BLA to the Food and Drug Administration for its COVID-19 vaccine
On Aug. 25, 2021, Moderna announced it had completed the rolling submission process for its Biologics License Application…
COVID-19 | Diagnostics | FDA | Medical Device
BD received EUA for first at-home COVID-19 test to use smartphone to interpret, deliver results
On Aug. 25, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had issued an…
Johnson & Johnson announced data to support boosting its single-shot COVID-19 vaccine
On Aug. 25, 2021, Johnson & Johnson announced data supporting the use of its COVID-19 vaccine as a…
Pfizer and BioNTech initiated rolling submission of SBLA to U.S. FDA for booster dose of COMIRNATY in individuals 16 and Older
On Aug. 25, 2021, Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to…
Medigen Vaccine Biologics announced launch of COVID-19 vaccine MVC-COV1901 with Dynavax’s CpG 1018 adjuvant
On Aug. 23, 2021, Dynavax Technologies and Biological E announced the execution of a commercial supply agreement of…
U.S. FDA approved first COVID-19 vaccine
On Aug. 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine, known…
Pfizer-BioNTech COVID-19 vaccine COMIRNATY received full U.S. FDA approval for individuals 16 years and older
On Aug. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…
Amyris achieved promising in-vivo results for intranasal delivery of RNA/NLC vaccine
On Aug. 20, 2021, Amyris announced promising in-vivo results in a study of its licensed RNA vaccine through…
UK authorized Regeneron antibody cocktail to prevent and treat acute COVID-19 infection
On Aug. 20, 2021, Regeneron announced that the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency had…
clinical trial tested donated antibodies for effectiveness in fighting infection caused by Coronavirus
On Aug. 19, 2021, Oregon Health & Science University (OHSU) announced that it was part of a randomized,…
Vaccines still effective against Delta variant of concern, says Oxford-led study of the COVID-19 Infections Survey
On Aug. 19, 2021, the University of Oxford reported that obtaining two vaccine doses remained the most effective…
Researchers developed COVID-19 severity screening method based on the Agilent Cary 630 FTIR spectrometer
On Aug. 18, 2021, Agilent Technologies announced that researchers at the Indian Institute of Technology Bombay in India…
NIH study showed no significant benefit of convalescent plasma for COVID-19 outpatients with early symptoms
On Aug. 18, 2021, the final results of the Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO)…
Antibodies elicited by COVID-19 vaccination effective against delta variant
On Aug. 17, 2021, researchers reported the delta variant of the virus that causes COVID-19 was not particularly…
NIH scientists developed faster COVID-19 test
On Aug. 16, 2021, scientists at the National Institutes of Health (NIH) announced they had developed a new…
Moderna announced supply agreement with Canada for expanded supply of COVID-19 Vaccine from 2022 – 2024
On Aug. 16, 2021, Moderna announced a revised supply agreement with the Government of Canada for up to…
Pfizer and BioNTech announced submission of initial data to FDA to support booster dose of COVID-19 vaccine
On Aug. 16, 2021, Pfizer and BioNTech announced that they had submitted Phase 1 data to the U.S….
COVID-19 | FDA | Life Science History | NIH
FDA declined to issue Rigel Pharma EUA for fostamatinib for teatment of COVID-19 in hospitalized adults
On Aug. 13, 2021, Rigel Pharma announced that the U.S. Food and Drug Administration (FDA) had informed the…
Moderna announced FDA authorization of third dose of COVID-19 vaccine for immunocompromised individuals
On Aug. 13, 2021, Moderna announced that the Food and Drug Administration (FDA) had approved an update to…
The Department of Veterans Affairs expanded mandate for COVID-19 vaccines among VHA employees
On Aug. 12, 2021, the U.S. Department of Veterans Affairs (VA) announced that it expanded his previous COVID-19…
Moderna announced study showing Its COVID-19 vaccine maintained antibodies against variants of concern
On Aug. 12, 2021, Moderna announced the publication of new data on the durability of the Moderna COVID-19…
Innovation Pharmaceuticals’ phase 2 clinical trial of Brilacidin for COVID-19 trial database under review in preparation for lock
On Aug. 12, 2021, Innovation Pharma released information regarding the status of its randomized, double-blind, placebo-controlled Phase 2…
COVID-19 | Therapeutics | WHO
WHO’s Solidarity clinical trial entered a new phase with three new candidate drugs
On Aug. 11, 2021, the World Health Organization (WHO) announced the next phase in its Solidarity trial that…
NIH launched study of third COVID-19 vaccine dose in kidney transplant recipients
On Aug. 10, 2021, the National Institutes of Health (NIH) announced that a pilot study had begun to…
Cardinal Health partnered with Abbott and Quidel to offer rapid OTC COVID-19 tests
On Aug. 10, 2021, Cardinal Health announced its efforts to commercialize and broaden access to over-the-counter rapid COVID-19…
Australian Therapeutic Goods Administration granted provisional registration for Moderna’s COVID-19 vaccine
On Aug. 9, 2021, Moderna announced that the Therapeutic Goods Administration (TGA) had granted provisional registration to the…
INOVIO and Advaccine receive regulatory allowance for prime-boost clinical trials in China using INO-4800, COVID-19 DNA vaccine candidate
On Aug. 9, 2021, Inovio Pharma announced that it had received regulatory allowance for two clinical trials investigating…
CDC reported vaccination offers higher protection than previous COVID-19 infection
On Aug. 6, 2021, the Centers for Disease Control and Prevention (CDC) annouced in MMWR that a study…
Novavax announced COVID-19 vaccine booster data demonstrating four-fold Increase in neutralizing antibody
On Aug. 5, 2021, Novavax announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle…
Lenzilumab treatment may provide enhanced likelihood of survival without ventilation in hospitalized black and African-American COVID-19 patients
On Aug. 4, 2021, Humanigen announced analysis of results from its Phase 3 LIVE-AIR study of lenzilumab in…