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…
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…
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…
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…
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…
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 | Life Science News | 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…
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 AdCOVIDï¾™ IND application
On Feb. 17, 2021, Altimmune announced that the FDA had cleared the Companyï¾’s Investigational New Drug (IND) application…
Meridian provided an update on the Revogeneï¾® SARS-CoV-2 EUA submission
On Feb. 16, 2021, Meridian Bioscience provided an update on its application for Emergency Use Authorization (EUA) with…
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 FDA had granted Emergency Use Authorization (EUA) for…
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…
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 FDA to a…
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 VBIï¾’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…
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…
Nirmidas Biotech received FDA Emergency Use Authorization for its COVID-19 rapid antibody fingerstick test
On Jan. 25, 2021, Nirmidas Biotech announced its second FDA Emergency Use Authorization (EUA) for their COVID-19 rapid…
FDA approved Aurinia Pharmaceuticalsï¾’ LUPKYNISï¾™ (voclosporin) for adults with active lupus nephritis
On Jan. 22, 2021, Aurinia Pharmaceuticals announced that the FDA had approved LUPKYNISTM (voclosporin) in combination with a…
FDA approved first extended-release, injectable drug regimen for adults living with HIV
On Jan. 21, 2021, the FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for…
Janssen announced FDA approval of CABENUVA, the first long-acting HIV treatment regimen
On Jan. 21, 2021, Janssen Pharmaceutical announced the FDA had approved CABENUVA (consisting of Janssenï¾’s rilpivirine and ViiV…
Mesa Biotech received 510(k) clearance and CLIA waiver for Its Accula Strep A Molecular Point of Care Test
On Jan. 19, 2021, Mesa Biotech announced it had received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA)…
Innovation Pharma’s Brilacidin for the treatment of COVID-19 received FDA Fast Track Designation
On Jan. 14, 2021, Innovation Pharmaceuticals announced that the FDA had designated as a Fast Track development program…