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…
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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…
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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…
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Biotechnology | COVID-19 | Diagnostics | 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 U.S….
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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…
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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…
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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’s Investigational New Drug application…
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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…
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Biotechnology | FDA | Oncology | Therapeutics
FDA approved first cell-based gene therapy for adult patients with multiple myeloma
On Mar. 27, 2021, the U.S. Food and Drug Administration (FDA) announced it had approved Abecma (idecabtagene vicleucel),…
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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…
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Biotechnology | FDA | Oncology | Therapeutics
FDA approved Bristol Myers Squibb’s and bluebird bio’s Abecma for Relapsed or Refractory Multiple Myeloma
On Mar. 26, 2021, Bristol Myers Squibb and bluebird bio announced that the U.S. Food and Drug Administration…
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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…
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FDA issued an EUA to the Twist Bioscience for their SARS-CoV-2 NGS assay.
On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to…
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Cepheid received Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
On Mar. 21, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
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FDA authorized first machine learning-based screening device to identify COVID-19 infection biomarkers
On Mar. 19, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the…
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FDA permitted marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
On Mar. 17, 2021, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory…
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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…
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Oragenics announced Material Transfer Agreement with Biodextris for mucosal adjuvant for intranasal COVID-19 vaccine
On Mar. 9, 2021, Oragenics announced it had entered into a material transfer agreement with Biodextris for the…
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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….
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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…
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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…
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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…
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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…
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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,…
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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…
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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…
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Biotechnology | Disease | FDA | Genomics | Therapeutics
FDA approved targeted treatment for rare Duchenne muscular dystrophy mutation
On Feb. 25, 2021, the U.S. Food and Drug Administration (FDA) granted approval to Sarepta Therapeutics for Amondys…
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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…
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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…
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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…
