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 companyﾒs Investigational New Drug application…
CytoDyn’s leronlimab decreased mortality at 14 days by 82% amongst critically Ill COVID-19 patients
On Mar. 30, 2021, CytoDyn announced further results from its CD12 trial of severe-to-critically ill patients with COVID-19….
Oxford University researchers released cheap, quick COVID-19 antibody test
On Mar. 29, 2021, an international research team led by Oxford University scientists announced they had developed a…
Humanigen reported positive phase 3 results demonstrating Lenzilumabﾙ improved survival without mechanical ventilation with COVID-19
On Mar. 29, 2021, Humanigen announced positive topline results from its Phase 3 clinical trial evaluating the efficacy…
Moderna announced shipment of 100 millionth dose of its COVID-19 vaccine to the U.S. Government
On Mar. 29, 2021, Moderna announced that the Company has shipped the 100-millionth dose of its COVID-19 vaccine…
GSK to manufacture Novavax’ COVID-19 vaccine
On Mar. 29, 2021, Novavax, GSK and the UK Government Vaccines Taskforce announced an agreement in principle to…
Johnson & Johnson announced agreement with African Vaccine Acquisition Trust for COVID-19 vaccine candidate
On Mar. 29, 2021, Janssen Pharmaceutica announced that it had entered into an agreement with the African Vaccine…
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…
BioNTech updated on vaccine production status at Marburg manufacturing site
On Mar. 26, 2021, BioNTech announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19…
Scientists found evidence that novel coronavirus infects the mouth’s cells
On Mar. 25, 2021, an international team of scientists announced they had found evidence that SARS-CoV-2 infects cells…
Clover Biopharma and Dynavax announcd first participants dosed in phase 2/3 trial for COVID-19 vaccine candidate
On Mar. 24, 2021, Clover Biopharmaceuticals and Dynavax Technologies announced the first participants have were dosed in Clover’s…
COVID-19 | Diagnostics | FDA
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…
CureVacﾒs COVID-19 vaccine candidate demonstrated protection against SARS-CoV-2 B1351 variant
On Mar. 23, 2021, CureVac announced publication of preclinical data demonstrating that their COVID-19 vaccine candidate, CVnCoV, protected…
Phase III data showed investigational antibody cocktail reduced hospitalisation or death in patients with COVID-19
On Mar. 23, 2021, Roche confirmed positive topline results from the largest trial to date assessing a COVID-19…
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…
Pfizer initiated phase 1 study of movel oral antiviral therapeutic agent against SARS-CoV-2
On Mar. 23, 2021, Pfizer announced that it was progressing to multiple ascending doses after completing the dosing…
Omeros and Quantum Leap announced first patients dosed with Narsoplimab in the I-SPY COVID-19 trial
On Mar. 23, 2021, Omeros and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in…
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…
CureVac expanded CVnCoV COVID-19 vaccine candidate clinical trial Aanalyses to include phase 2b/3 variant
On Mar. 22, 2021, CureVac announced plans to expand and further specify the protocols of its ongoing late-stage…
Investigational AstraZeneca vaccine prevented COVID-19
On Mar. 22, 2021, the NIH announced that results from a large clinical trial in the U.S. and…
US, Chile and Peru interim trial data showed Oxford-AstraZeneca vaccine was safe and highly effective
On Mar. 22, 2021, Oxford University announced that a Phase III study of the Oxford-AstraZeneca coronavirus vaccine conducted…
AIM ImmunoTech announced addition of single-agent Ampligen arm to Cancer Center’s study in cancer patients with COVID-19
On Mar. 22, 2021, AIM ImmunoTech announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer…
Moderna announced supply agreement with the Philippines for 7 million additional doses of COVID-19 Vaccine Moderna
On Mar. 22, 2021, Moderna announced that the Philippines had secured 7 million additional doses of COVID-19 Vaccine…
Cepheid received Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
On Mar. 21, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
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…
UK and EU regulatory agencies confirmed COVID-19 Vaccine AstraZeneca was safe and effective
On Mar. 18, 2021, AstraZeneca announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines…
XPhyto announces European approval for 25 minute COVID-19 PCR test
On Mar. 18, 2021, XPhyto and 3a-diagnostics announced the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test…
Incyte announced results from phase 3 DEVENT study evaluating Jakafi as treatment for patients with COVID-19
On Mar. 18, 2021, Incyte announced results from the Phase 3 DEVENT study evaluating the efficacy and safety…
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…