FDA cleared IND for iNKT Cells to treat COVID-19 patients
On Jun. 2, 2020, Agenus announced the U.S. Food and Drug Administration’s (FDA) clearance of AgenTus’ IND application…
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FDA issued Emergency Use Authorization for Impella RP as therapy for COVID-19 patients with right heart failure
On Jun. 1, 2020, the Food and Drug Administration (FDA) announced it had issued an emergency use authorization…
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Altimmune launched clinical trial of T-COVIDTM, an investigational intranasal immune modulator for treatment of patients with early COVID-19
On Jun. 1, 2020, Altimmune announced the U.S. Food and Drug Administration (FDA) had authorized the Company to…
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FDA authorized OPKO Health clinical trial evaluating RAYALDEE in COVID-19 patients
On Jun. 1, 2020, OPKO Health announced the U.S. Food and Drug Administration (FDA) had authorized OPKO to…
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The FDA streamlined development of tests with at-home sample collection
On May 29, 2020, the U.S. Food and Drug Administration (FDA) took steps to further support the development…
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The FDA approved first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
On May 28, 2020, the FDA approved Avid Radiopharmaceuticals’ Tauvid (flortaucipir F18) for intravenous injection, the first drug…
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FDA authorized Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for emergency use
On May 28, 2020, Quest Diagnostics announced it had received emergency use authorization (EUA) from the U.S. Food…
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Philips launched next generation wearable biosensor for early patient deterioration detection for COVID-19
On May 26, 2020, Royal Philips announced it had received 510(k) clearance from the FDA for its wearable…
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The FDA approved only drug in the U.S. to treat severe malaria
On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved artesunate for injection to treat severe…
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Meridian Bioscience supply reagents for manufacturing of tens of millions of COVID-19 antibody tests per month
On May 26, 2020, Meridian Bioscience announced that its SARS-CoV-2 antigens and related reagents are part of assays…
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The FDA approved only drug in U.S. to treat severe malaria
On May 26, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Amivas’ artesunate for…
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OraSures OMNIgene-ORAL kit included in EUA granted to P23 labs for at-home collection of saliva samples for SARS-CoV-2 test
On May 22, 2020, OraSure Technologies announced that its OMNIgene-ORAL saliva collection device (OM-505) was included in the…
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The FDA posted list of antibody tests removed from the ‘notification list’ of tests being offered during the public health emergency
On May 21, 2020, the U.S. Food and Drug Administration (FDA) posted list of antibody tests removed from…
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Montefiore-Einstein Scientists lead two trials of leronlimab for treatment of severe lung inflammation in COVID-19 patients
On May 21, 2020, Montefiore Health System and Albert Einstein College of Medicine were the first sites in…
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Roche highly accurate antibody test for COVID-19 went live at more than 20 initial lab sites in the US
On May 19, 2020, Roche announced its Elecsys Anti-SARS-CoV-2 antibody test is live at more than 20 commercial…
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NantKwest announced FDA authorization of IND application for mesenchymal stem cell product for treatment of severe COVID-19 patients
On May 18, 2020, NantKwest, now part of ImmunityBio, announced it had received authorization from the U.S. Food…
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Quidel’s Lyra Direct SARS-CoV-2 assay received Emergency Use Authorization and CE Mark for molecular detection of COVID-19
On May 18, 2020, Quidel announced it had received Emergency Use Authorization (EUA) for the Lyra Direct SARS-CoV-2…
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FDA cleared IND application to enable phase II trial of ViralClear’s merimepodib to treat adult patients with advanced COVID-19 to proceed
On May 18, 2020, BioSig Technologies and its subsidiary, ViralClear Pharmaceuticals, announced the U.S. Food and Drug Administration…
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Hologic granted FDA Emergency Use Authorization for its second molecular test for COVID-19
On May 15, 2020, Hologic announced it had received Emergency Use Authorization (EUA) from the U.S. Food and Drug…
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The FDA informed public about possible accuracy concerns with Abbott ID NOW point-of-care test
On May 14, 2020, the U.S. Food and Drug Administration (FDA) alerted the public to early data that…
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Biotechnology | Cardiology | COVID-19 | FDA | Imaging | Infectious Disease
Philips received FDA clearance for use of ultrasound portfolio to manage COVID-19-related lung and cardiac complications
On May 13, 2020, Royal Philips announced that it has received 510(k) clearance from the U.S. Food and Drug…
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Thermo Fisher Scientific response to COVID-19 expanded to include new serology test
On May 13, 2020, Thermo Fisher Scientific announced it will expand its response to the COVID-19 pandemic by…
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Abbott received FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity mﾙ System
On May 12, 2020, Abbott announced the U.S. Food and Drug Administration (FDA) had issued an Emergency Use…
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Moderna received FDA Fast Track Designation for mRNA vaccine (mRNA-1273) against novel Coronavirus
On May 12, 2020, Moderna announced the U.S. Food and Drug Administration (FDA had granted Fast Track designation…
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FDA further expanded EUA for Thermo Fisher Scientific’s COVID-19 diagnostic tests
On May 12, 2020, Thermo Fisher Scientific announced the FDA has further expanded emergency use authorization (EUA) for…
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Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics | WHO
Mylan to supply investigational antiviral remdesivir for potential treatment of COVID-19
On May 12, 2020, Mylan announced, as part of its ongoing efforts to support patients and public health…
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The FDA announced actions to accelerate development of novel prevention, treatment options for COVID-19
On May 11, 2020, the U.S. Food and Drug Administration (FDA) announced actions to accelerate the development of…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
NIH report coordinated strategy to accelerate multiple COVID-19 vaccine candidates is key
On May 11, 2020, a harmonized and collaborative approach to the clinical testing, scale-up and distribution of candidate…
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Abbott received FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System
On May 11, 2020, Abbott announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA)…
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Todos Medical entered Into exclusive distribution agreement with Gnomegen and received FDA Emergency Use Authorization for COVID-19 qPCR test kits
On May 11, 2020, Todos Medical announced an exclusive distribution agreement with Gnomegen for the distribution of its…
