FDA revoked Emergency Use Authorization for monoclonal antibody bamlanivimab
On Apr. 16, 2021, the FDA revoked the emergency use authorization (EUA) that allowed for Eli Lilly’s investigational…
FDA authorized new high-throughput, automated system for leading COVID-19 test
On Apr. 12, 2021, Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) had granted…
The FDA issued an EUA to Symbiotica for the COVID-19 self-collected antibody test system
On Apr. 5, 2021, the FDA issued an Emergency Use Authorization (EUA) to Symbiotica for the COVID-19 Self-Collected…
FDA revised Moderna COVID-19 vaccine EUA to increase the number of vaccine doses available
On Apr. 1, 2021, the FDA announced two revisions regarding the number of doses per vial available for…
Moderna provided storage update and FDA authorization for 15-doses per vial of COVID-19 vaccine
On Apr. 1, 2021, Moderna announced that based on submitted stability data, the U.S. Food and Drug Administration…
BD received EUA for asymptomatic screening for SARS-CoV-2 through Serial Rapid Antigen Testing
On Apr. 1, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had granted Emergency…
Quidel’s QuickVue At-Home OTC COVID-19 Test received EUA for screening use with serial testing
On Mar. 31, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA,…
OraSure Technologies submitted COVID-19 rapid antigen prescription home self-test to FDA for EUA
On Mar. 30, 2021, OraSure Technologies announced that it had submitted an application to the U.S. Food and…
Qx Therapeutics received FDA authorization with IND for QXT-101 in phase 2 trial for patients with COVID-19 infection.
On Mar. 30, 2021, Qx Therapeutics announced that the FDA had cleared the companyï¾’s Investigational New Drug application…
Philippines FDA approved the use of leronlimab to treat a COVID-19 patient
On Mar. 29, 2021, CytoDyn announced that the Republic of the Philippines, Department of Health, Food and Drug…
FDA approved first cell-based gene therapy for adult patients with multiple myeloma
On Mar. 27, 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients…
FDA approved first in the world device to treat patients with congenital heart disease
On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) approved the first in the world non-surgical…
FDA approved Bristol Myers Squibbï¾’s and bluebird bioï¾’s Abecma for Relapsed or Refractory Multiple Myeloma
On Mar. 26, 2021, Bristol Myers Squibb and bluebird bio announced that the FDA had approved Abecma (idecabtagene…
AXIM Biotechnologies’ partner Empowered filed EUA with FDA for use of rapid COVID-19 neutralizing antibody test
On Mar. 24, 2021, AXIM Biotechnologies announced that partner Empowered Diagnostics, had filed an Emergency Use Authorization or…
FDA issued an EUA to the Twist Bioscience for their SARS-CoV-2 NGS assay.
On Mar. 26, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience for their…
Positive leronlimab treatment in critically Ill COVID-19 patient published
On Mar. 23, 2021, CytoDyn announced the publication in the Journal of Translational Autoimmunity ‘Case study of a…
FDA authorized first machine learning-based screening device to identify COVID-19 infection biomarkers
On Mar. 19, 2021, the FDA issued an emergency use authorization to Tiger Tech Solutions for the first…
FDA permitted marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
On Mar. 17, 2021, the FDA granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic…
The FDA granted Department of Veterans Affairs first ever compassionate use for 3D-printed hearing device
On Mar. 11, 2021, the Department of Veterans Affairs (VA) announced that it had received compassionate use approval…
Adaptive Biotechnologies announced FDA EUA for T-Detect COVID to confirm prior COVID-19 infection
On Mar. 5, 2020, Adaptive Biotechnologies announced that the U.S. Food and Drug Administration (FDA) had issued an…
FDA authorized Cue Health’s COVID-19 test for at-mome and Over The Counter Use
On Mar. 5, 2021, Cue Health announced it had received Emergency Use Authorization (EUA) from the U.S. Food…
Luminex received FDA Emergency Use Authorization and CE Mark for expanded NxTAG panel test Including SARS-CoV-2
On Mar. 4, 2021, Luminex announced that it had received Emergency Use Authorization (EUA) from the U.S. Food…
Resverlogix published evidence of apabetalone’s beneficial effects on COVID-19
On Mar. 3, 2021, Resverlogix and QIMR Berghofer Medical Research Institute announced the publishing of an article providing…
Quidel received Emergency Use Authorization for QuickVue at-home COVID-19 test
On Mar. 1, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA,…
Johnson & Johnson single-shot COVID-19 vaccine authorized by US FDA for Emergency Use
On Feb. 27, 2021, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) had issued…
Johnson & Johnson COVID-19 vaccine candidate recommended for EUA by FDA advisory committee
On Feb. 26, 2021, Johnson & Johnson announced that the FDA Vaccines and Related Biological Products Advisory Committee…
Biotechnology | Disease | FDA | Genomics | Life Science News | Therapeutics
FDA approved targeted treatment for rare Duchenne muscular dystrophy mutation
On Feb. 25, 2021, the FDA granted approval to Sarepta Therapeutics for Amondys 45 (casimersen) injection for the…
Adamis Pharma sleared to proceed with human studies of Tempol for the treatment of COVID-19
On Feb. 22, 2021, Adamis Pharma announced that the FDA had completed the safety review of the Companyï¾’s…
Pfizer and BioNTech submited COVID-19 vaccine stability data at standard freezer temperature to the FDA
On Feb. 19, 2021, BioNTech announced the submission of new data to the FDA demonstrating the stability of…
Luminex received BARDA funding to support development and validation of test combining SARS-CoV-2 and Flu/RSV respiratory pane
On Feb. 19, 2021, Luminex announced that it had received $11.3 million in funding from the Biomedical Advanced…