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….
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…
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…
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…
Biotechnology | Disease | FDA
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…
Biotechnology | COVID-19 | FDA
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…
Biotechnology | COVID-19 | FDA
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 | 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…
Biotechnology | COVID-19 | FDA | Pharmaceutical | Therapeutics | Vaccine
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…
Agilent announced immunoassay kit to detect SARS-CoV-2 antibodies
On Feb. 18, 2021, Agilent Technologies announced the launch of the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay…
Altimmune announced FDA clearance of AdCOVIDﾙ IND application
On Feb. 17, 2021, Altimmune announced that the FDA had cleared the Companyﾒs Investigational New Drug (IND) application…
Meridian provided an update on the Revogeneﾮ SARS-CoV-2 EUA submission
On Feb. 16, 2021, Meridian Bioscience provided an update on its application for Emergency Use Authorization (EUA) with…
COVID-19 | Diagnostics | FDA | Medical Device
BD announced EUA, CE Mark for combination molecular diagnostic to detect SARS-CoV-2, influenza A+B in single test
On Feb. 12, 2021, BD (Becton, Dickinson) announced that the U.S. Food and Drug Administration (FDA) had granted…
ImmunityBio and NantKwest announced FDA authorization to study hAd5 T-cell COVID-19 vaccine
On Feb. 11, 2021, ImmunityBio and NantKwest announced they had received FDA authorization to expand Phase I testing…
Qatar Ministry of Public Health issued Emergency Use Authorization for COVID-19 Vaccine Moderna
On Feb. 11, 2021, Moderna announced that the Qatar Ministry of Public Health had issued an emergency use…
Tonix Pharmaceuticals to develop COVID-19 skin test to measure SARS-CoV-2 exposure and T cell immunity
On Feb. 8, 2021, Tonix Pharmaceuticals announced it had received the written response from the U.S. Food and…
FDA approved new treatment for adults with relapsed or refractory large-B-Cell lymphoma
On Feb. 5, 2021, the FDA approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients…
VBI Vaccines announced FDA Acceptance of BLA filing for VBIﾒs 3-antigen prophylactic hepatitis B vaccine
On Feb. 2, 2021, VBI Vaccines announced that the FDA had accepted its filing of the Biologics License…
Biotechnology | COVID-19 | FDA
Precipio launched COVID-19 antibody testing at point-of-care
On Jan. 28, 2021, Precipio announced that following receipt of an Emergency Use Authorization from the U.S. Food…