The FDA authorized first next generation sequence test for diagnosing COVID-19
On Jun. 10, 2020, the FDA issued an emergency use authorization (EUA) to Illumina for the first COVID-19…
Illumina received first FDA Emergency Use Authorization for sequencing-based COVID-19 diagnostic test
On Jun. 9, 2020, Illumina announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization…
Quidel’s received amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay
On Jun. 9, 2020, Quidel announced it had received an amended Emergency Use Authorization (EUA) from the FDA,…
Immunic announced FDA allowance of its phase 2, CALVID-1 clinical trial of IMU-838 in COVID-19
On Jun. 9, 2020, Immunic announced receipt of regulatory allowance from the FDA to initiate its phase 2,…
OraSure’s Oragene-Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test
On Jun. 8, 2020, OraSure Technologies announced that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for…
The FDA approved antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
On Jun. 4, 2020, the FDA approved Merck’s Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired…
FDA cleared IND for iNKT Cells to treat COVID-19 patients
On Jun. 2, 2020, Agenus announced the FDA’s clearance of AgenTus’ IND application for an allogeneic iNKT therapy….
FDA issued Emergency Use Authorization for Impella RP as therapy for COVID-19 patients with right heart failure
On Jun. 1, 2020, the FDA issued an emergency use authorization (EUA) for Impella RP to include patients…
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 FDA had authorized the Company to proceed with a clinical trial…
FDA authorized OPKO Health clinical trial evaluating RAYALDEE in COVID-19 patients
On Jun. 1, 2020, OPKO Health announced the FDA had authorized OPKO to undertake a Phase 2 trial…
The FDA streamlined development of tests with at-home sample collection
On May 29, 2020, the FDA took steps to further support the development of COVID-19 tests for at-home…
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…
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 FDA for…
The FDA approved only drug in U.S. to treat severe malaria
On May 26, 2020, the FDA approved Amivas’ artesunate for injection to treat severe malaria in adult and…
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…
The FDA approved only drug in the U.S. to treat severe malaria
On May 26, 2020, the FDA provided approval to Amivas for its artesunate for injection to treat severe…
Meridian Bioscience suppied 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…
Diffusion Pharmaceuticals received accelerated FDA response to proposed TSC COVID-19 clinical trial program
On May 26, 2020, Diffusion Pharmaceuticals announced it had received an accelerated response from the FDA to the…
Biotechnology | COVID-19 | FDA
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…
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 FDA posted list of antibody tests removed from the ‘notification list’ of tests…
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…
The FDA announced an agreement with Aetion to collaborate on advanced analytical techniques to accelarate Coronavirus disease research
On May 19, 2020, the FDA announced an agreement with Aetion to collaborate on advanced analytical techniques to…
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 Elecsysï¾® Anti-SARS-CoV-2 antibody test is live at more than 20 commercial…
NantKwest announced FDA authorization of IND application for mesenchymal stem cell product for treatment of severe COVID-19 patients
On May 18, 2020, NantKwest announced it had received authorization from the FDA for an Investigational New Drug…
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…
FDA cleared IND application to enable phase II trial of ViralClearï¾’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 FDA has completed its review…
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 FDA for its…
The FDA informed public about possible accuracy concerns with Abbott ID NOW point-of-care test
On May 14, 2020, the FDA alerted the public to early data that suggest potential inaccurate results from…
AIM ImmunoTech announced FDA authorization for first human ampligen trial in COVID-19 patients with cancer
On May 14, 2020, AIM ImmunoTech announced the FDA authorized the first human trial assessing the safety and…
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 had received 510(k) clearance from the FDA to market…