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 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…
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…
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…
Abbott received FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity mï¾™ System
On May 12, 2020, Abbott announced the FDA issued an Emergency Use Authorization (EUA) for the company’s molecular…
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…
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…
The FDA announced actions to accelerate development of novel prevention, treatment options for COVID-19
On May 11, 2020, the FDA announced actions to accelerate the development of prevention and treatment options for…
Biotechnology | COVID-19 | FDA
Abbott received FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System
On May 11, 2020, Abbott announced the FDA issued an Emergency Use Authorization (EUA) for the company’s SARS-CoV-2…
Bellerophon Therapeutics submited investigational NDA to study INOpulse inhaled nitric oxide for treatment of COVID-19
On May 11, 2020, Bellerophon Therapeutics announced the FDA accepted its Investigational New Drug (IND) application, allowing the…
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…
The FDA issued EUA for first antigen test to help in rapid detection of virus that causes COVID-19 in patients
On May 8, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA)…
The FDA issued EUA for first diagnostic test using at-home collection of saliva specimens
On May 8, 2020, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for…
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…
Biotechnology | CDC | COVID-19 | FDA
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…
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…
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 FDAï¾’s Center…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | 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…
FDA provided Emergency Use Authorization to PerkinElmer for serological test to identify COVID-19 antibodies
On May 5, 2020, PerkinElmer announced the FDA provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company)…
Organicell announces FDA approval of IND application for treatment of SARS due to COVID-19
On May 5, 2020, Organicell Regenerative Medicine announced the FDA has approved the Investigational New Drug application for…