Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)
On Oct. 14, 2020, Regeneron announced that the FDA had approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the…
FDA approved first treatment for Ebola virus
On Oct. 14, 2020, the FDA approved Regeneron Pharmaceutical’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three…
Vaxart announced positive hamster challenge study data for its oral COVID-19 vaccine
On Oct. 14, 2020, Vaxart announced that the FDA had completed its review of the Companyﾒs Investigational New…
Tevogen Bio submitted IND for T cell treatment in COVID-19
On Oct. 14, 2020, Tevogen Bio announced that its Investigational New Drug (IND) application to develop a COVID-19…
Roche launched laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
On Oct. 13, 2020, Roche announced that it intended to launch a high-volume SARS-CoV-2 Antigen test as an…
New CAR T-Cell therapy approved and available at Roswell Park for lymphoma patients
On Oct. 13, 2020, Roswell Park Comprehensive Cancer Center announced that it had been approved to administer the…
FDA awarded grants to fund clinical trials to advance development of products for treatment of rare diseases
On Oct. 8, 2020, the FDA announced that it had awarded six new clinical trial research grants to…
Biotechnology | COVID-19 | Diagnostics | FDA
Abbott’s released ID NOW COVID-19 interim clinical study results to provide facts on clinical performance
On Oct. 7, 2020, in a continuing effort to provide the facts about ID NOW to support public…
FDA broadly supported Oragenicsﾒ pre-IND development program for its SARS-CoV-2 vaccine
On Oct. 6, 2020, Oragenics announced receipt of feedback to its Type B Pre-IND Meeting Request from the…
FDA amended EUA for Hologicﾒs Aptima SARS-CoV-2 assay to Include COVID-19 testing of asymptomatic individuals
On Oct. 6, 2020, Hologic announced that its Aptimaﾮ SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA)…
FDA awarded contract to Stanford University to perform in-depth analysis of tissue samples to learn how SARS-CoV-2 causes COVID-19
On Oct. 5, 2020, the FDA awarded a research contract to the Stanford University School of Medicine to…
Data from Corvus phase 1 study of CPI-006 continued to support its potential as treatment for COVID-19
On Oct. 5, 2020, Corvus Pharmaceuticals announced that it has initiated a Phase 1 study to investigate a…
FDA approved drug combination for treating mesothelioma
On Oct. 1, 2020, the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment…
LabCorp COVID-19 molecular test innovation received FDA authorization
On Oct. 2, 2020, LabCorp announced that it had received an Emergency Use Authorization (EUA) from the FDA…
Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of two
On Sept. 29, 2020, Oxford Immunotec announced that it had received clearance from the FDA to amend the…
Windtree announced FDA acceptance of IND application for phase 2 clinical trial studying KL4 Surfactant in acute lung injury in adults with COVID-19
On Sept. 29, 2020, Windtree Therapeutics announced that FDA had accepted its Investigational New Drug application for a…
Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
INOVIO reported FDA partial clinical hold for planned phase 2/3 trial of COVID-19 vaccine candidate INO-4800
On Sept. 28, 2020, INOVIO announced the U.S. Food and Drug Administration (FDA) had notified the company that…
Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 assay
On Sept. 28, 2020, Hologic announced that its Panther Fusionﾮ SARS-CoV-2 assay had received Emergency Use Authorization (EUA)…
FDA took actions to help lower US prescription drug prices
On Sept. 24, 2020, the U.S. Department of Health and Human Services and the U.S. Food and Drug…
FDA authorized first point-of-care antibody test for COVID-19
On Sept. 23, 2020, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care…
FDA launched the Digital Health Center of Excellence
On Sept. 22, 2020, the FDA announced it had launched the Digital Health Center of Excellence within the…
Roche launched new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
On Sept. 18, 2020, Roche announced the launch of its Elecsysﾮ Anti-SARS-CoV-2 S antibody test for markets accepting…
COVID-19 | FDA | Therapeutics
AXIM Biotechnologies filed Emergency Use Authorization with COVID-19 rapid diagnostic test for neutralizing antibodies
On Sept. 16, 2020, AXIM Biotechnologies announced that it had filed an Emergency Use Authorization (EUA) application with…
FDA contracted with global partners to analyze coronavirus samples
On Sept. 15, 2020, the FDA awarded a $5.4 million research contract to the University of Liverpool and…
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Life Science History | Medical Device
FDA published comparative performance data for COVID-19 molecular diagnostic tests
On Sept. 15, 2020, the FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The…
Vaxart announced FDA clearance of IND application for oral COVID-19 vaccine
On Sept. 14, 2020, Vaxart announced that the FDA had completed its review of the Companyﾒs Investigational New…
BioNTech and Pfizer proposed expansion of pivotal COVID-19 vaccine trial
On Sept. 12, 2020, Pfizer and BioNTech announced that they had submitted an amended protocol to the FDA…
Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.
On Sept. 11, 2020, Todos Medical announced that the FDA has added the TODOS 2019-nCoV RT-qPCR Detection Kit…
Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 Individual IgM and IgG antibody tests
On Sept. 10, 2020, Accelerate Diagnostics and BioCheck announced that the FDA had issued an Emergency Use Authorization…
Pfizer and BioNTech to potentially supply EU with 200 million doses of mRNA-based vaccine candidate against SARS-CoV-2
On Sept. 9, 2020, Pfizer and BioNTech announced that they had submitted an amended protocol to the FDA…