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…
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Biotechnology | COVID-19 | Diagnostics | FDA
The FDA issued EUA for first antigen test to help in rapid detection of virus that causes COVID-19 in patients
On May 9, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA)…
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The FDA issued EUA for first diagnostic test using at-home collection of saliva specimens
On May 8, 2020, the U.S. Food and Drug Administration (FDA) announced it had issued the first emergency…
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RedHill Biopharma received FDA approval for COVID-19 clinical study with opaganib in the U.S.
On May 8, 2020, RedHill Biopharma announced the U.S. Food and Drug Administration (FDA) had approved its Investigational…
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Biotechnology | CDC | COVID-19 | Diagnostics | FDA | Infectious Disease
Quidel’s received Emergency Authorization for Rapid Antigen COVID-19 diagnostic assay
On May 8, 2020, Quidel announced it had received Emergency Use Authorization (EUA) from the FDA to market…
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Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Medical Device | Non-Profit Research
OPTI Medical Systems received FDA Emergency Use Authorization for OPTI SARS-CoV-2 RNA PCR test kit for detection of Virus causing COVID-19
On May 7, 2020, OPTI Medical Systems, an IDEXX Laboratories subsidiary announced the U.S. Food and Drug Administration…
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PharmaCyte Biotech received medical devices registration and submited pre-EUA application to the FDA for COVID-19 diagnostic kit
On May 6, 2020, PharmaCyte Biotech announced it had received Medical Devices Establishment Registration with the U.S. Food and…
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3M and Ford begin shipping newly designed powered air-purifying respirators for health care workers fighting COVID-19
On May 6, 2020, 3M and Ford announced that newly designed powered air-purifying respirators (PAPRs), developed are on…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics
FDA approved first targeted therapy to treat aggressive form of lung cancer
On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved Tabrecta (capmatinib) for the treatment of…
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ACON Laboratories announced international availability of SARS-CoV-2 rapid test
On May 5, 2020, ACON Laboratories announced the availability of its SARS-COV-2 IgG/IgM Rapid Test. ACON’s test is…
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BIOFIRE respiratory panel 21 (RP21) with SARS-CoV-2 obtained FDA Emergency Use Authorization
On May 4, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has…
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Vir and Alnylam identified RNAi therapeutic development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for treatment of COVID-19
On May 4, 2020, Vir Biotech and Alnylam Pharma announced the selection of a development candidate for VIR-2703,…
