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 Elecsysï¾® Anti-SARS-CoV-2 S antibody test for markets accepting…
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 Companyï¾’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…
COVID-19 | FDA | HIV | Life Science News | Vaccine
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…
FDA approved Trelegy Ellipta as first once-daily single inhaler triple therapy for treatment of both asthma and COPD in the U.S.
On Sept. 10, 2020, GlaxoSmithKline and Innoviva announced the U.S. Food and Drug Administration (FDA) had approved a…
INOVIO added Thermo Fisher Scientific to global manufacturing consortium
On Sept. 8, 2020, INOVIO announced that Thermo Fisher Scientific, the world leader in serving science, had signed…
Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systems
On Sept. 4, 2020, Roche announced that the cobasï¾® SARS-CoV-2 & Influenza A/B Test for use on the…
OraSure’s ORAcollect-RNA device Included in EUA granted to MiraDx for SARS-CoV-2 test
On Sept. 3, 2020, OraSure Technologies announced that its ORAcollect-ï¾·RNA (OR-100) collection device was included along with other…
Roche received FDA approval for first HIV-1/HIV-2 Qualitative test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
On Sept. 1, 2020, Roche announced FDA approval for the cobasï¾® HIV-1/HIV-2 Qualitative Test for use on the…
COVID-19 | Disease | FDA | Therapeutics
City of Hope doctors lead novel clinical trial to treat cancer patients with COVID-19
On Sept. 1, 2020, City of Hope announced that it was investigating an innovative treatment for cancer patients…
T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic test
On Aug. 31, 2020, T2 Biosystems announced that the FDA had issued an Emergency Use Authorization (EUA) for…
FDA expanded Emergency Use Authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19
On Aug. 28, 2020, the FDA issued an emergency use authorization (EUA) to Yale School of Public Health…
Gileadï¾’s investigational antiviral Vekluryï¾® (remdesivir) received FDA Emergency Use Authorization for treatment of patients with moderate COVID-19
On Aug. 28, 2020, Gilead Sciences announced the FDA expanded the Emergency Use Authorization (EUA) enabling use of…
Laurent Pharmaceuticals received FDA approval to initiate its COVID-19 phase 2 clinical trial in the U.S.
On Aug. 27, 2020, Laurent Pharmaceuticals announced that it had received approval from the U.S. Food and Drug…
Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test for healthcare professionals received FDA Emergency Use Authorization
On Aug. 26, 2020, Abbott announced the FDA had issued Emergency Use Authorization (EUA) for its BinaxNOWï¾™ COVID-19…
XBiotech announced COVID-19 candidate therapy
On Aug. 24, 2020, XBiotech announced that the FDA issued an emergency use authorization (EUA) for COVID-19 Convalescent…
FDA issued Emergency Use Authorization for convalescent plasma as potential promising COVIDï¾–19 treatment
On Aug. 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the…
Mayo Clinic discontinued enrollment in Expanded Access Program for convalescent plasma with FDA Emergency Use Authorization
On Aug. 23, 2020, the Mayo Clinic announced that with the FDA Emergency Use Authorization of convalescent plasma,…
Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 antibody testing system
On Aug. 19, 2020, Accelerate Diagnostics and BioCheck announced that the FDA had issued an Emergency Use Authorization…
FDA approved teatment for rare disease affecting optic nerves, spinal cord
On Aug. 17, 2020, the FDA approved Genentech’s Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder…
FDA issued Emergency Use Authorization to Yale School of Public Health for SalivaDirect method of saliva sample processing
On Aug. 15, 2020, the FDA issued an emergency use authorization (EUA) to Yale School of Public Health…
Quick and affordable saliva-based COVID-19 test developed by Yale scientists received FDA Emergency Use Authorization
On Aug. 15, 2020, a saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public…
Baxter obtained FDA Emergency Use Authorizations for HF20 set and ST set used in CRRT during Covid-19 pandemic
On Aug. 12, 2020, Baxter announced it had received Emergency Use Authorizations (EUAs) from the FDA for the…