Pfizer and BioNTech received first U.S. EUA of COVID-19 vaccine in adolescents
On May 10, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
Pfizer and BioNTech initiated rolling submission of Biologics License Application for FDA approval of COVID-19 vaccine
On May 7, 2021, Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the…
Biotechnology | COVID-19 | Diagnostics | FDA
Precipio launched Rapid COVID-19 Antibody test on Amazon platform
On May 3, 2021, Precipio announced that it had successfully launched its COVID-19 rapid antibody test (20 minute)…
FDA approved treatment for chronic kidney disease
On Apr. 30, 2021, the FDA approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney…
FDA revoked the EUA of the Battelle CCDS Critical Care Decontamination System
On Apr. 30, 2021, the FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care…
FDA completed inspection of Emergent BioSolutions vaccine production facility
On Apr. 21, 2021, the FDA announced that it had completed an inspection of the Emergent BioSolutions and…
FDA approved first immunotherapy for initial treatment of gastric cancer
On Apr. 16, 2021, the FDA approved Bristol-Myers Squibb’ s Opdivo (nivolumab), in combination with certain types of…
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…
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…
FDA revised Moderna COVID-19 vaccine EUA to increase the number of vaccine doses available
On Apr. 1, 2021, the U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of…
Biotechnology | COVID-19 | FDA
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,…
BD announced FDA Emergency Use Authorization for combination COVID-19, flu rapid antigen test
On Mar. 30, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) granted emergency use…
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…
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 Squibbﾒs and bluebird bioﾒ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…
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…
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…
Luminex submitted joint SARS-CoV-2 and Flu/RSV respiratory panel to FDA for Emergency Use Authorization
On Mar. 10, 2021, Luminex announced that it had submitted an Emergency Use Authorization application to the U.S….
Biotechnology | COVID-19 | Diagnostics | FDA
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…
Abbott’s received FDA EUA for laboratory PCR assay that detects and differentiates SARS-CoV-2, Flu A, Flu B and RSV
On Mar. 5, 2021, Abbott announced the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for…