LivaNova permitted to modify cardiopulmonary products’ indications for use to include ECMO therapy to address COVID-19
On Apr. 22, 2020, LivaNova announced that several of its cardiopulmonary products are now permitted to be used…
FDA granted ALung Emergency Use Authorization to Hemolung Respiratory Assist System for treatment of COVID-19
On Apr. 22, 2020, ALung Technologies announced the U.S. Food and Drug Administration (FDA) granted the Company Emergency…
Biotechnology | Disease | FDA | Oncology | Therapeutics
The FDA approved new therapy for triple negative breast cancer
On Apr. 22, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy),…
Quidel’s Lyra direct SARS-CoV-2 assay submitted for Emergency Use Authorization for molecular detection of COVID-19
On Apr. 22, 2020, Quidel announced it has applied for an Emergency Use Authorization (EUA) for the Lyraﾮ…
LabCorp COVID-19 at-home test kit received FDA Emergency Use Authorization
On Apr. 21, 2020, LabCorpﾮ announced it has received an Emergency Use Authorization (EUA) from the FDA. The…
Biotechnology | COVID-19 | Diagnostics | FDA | Therapeutics
Todos Medical announced FDA Emergency Use Authorization allowed for Gnomegen COVID-19 PCR test kits
On Apr. 21, 2020, Todos Medical announced that Gnomegen has received Emergency Use Authorization from the FDA for…
FDA approved IMBRUVICA (ibrutinib) plus Rituximab for ttreatment of patients with CLL
On Apr. 21, 2020, the Janssen Pharmaceutical Companies of Johnson & Johnson announced U.S. Food and Drug Administration…
aTyr Pharma announced phase 2 study of ATYR1923 in COVID-19 patients with severe respiratory complications
On Apr. 21, 2020, aTyr Pharma announced the FDA has accepted its Investigational New Drug application to evaluate…
ViralClear submited application for Vicromax through FDAs Coronavirus Treatment Acceleration Program for accelerated clinical trials
On Apr. 21, 2020, BioSig Technologies announced that subsidiary ViralClear Pharmaceuticals, had submitted an application for Vicromax(tm) (merimepodib,…
Novartis announced plan to initiate clinical study of Jakavi in severe COVID-19 patients
On Apr. 20, 2020, Novartis announced it had reached an agreement with the U.S. Food and Drug Administration…
Alexion announced plans to initiate phase 3 study of ULTOMIRISﾮ (ravulizumab-cwvz) in hospitalized patients with severe COVID-19
On Apr. 20, 2020, Alexion announced plans to initiate a global Phase 3 study to investigate ULTOMIRISﾮ (ravulizumab-cwvz)…
Screening of 11,552 compounds identified Innovation Pharma’s Brilacidin as promising Potential inhibitors of novel Coronavirus COVID-19
On Apr. 20, 2020, Innovation Pharma reported that based on molecular screening of 11,552 compounds comprising already FDA-approved…
Atossa Therapeutics submitted Clinical Investigation approval to FDA for launch of COVID-19 HOPE study
On Apr. 20, 2020, Atossa Therapeutics announced that it had applied to the FDA for approval to commence…
Biotechnology | Disease | FDA | Oncology | Therapeutics
FDA approved first new drug under international collaboration for patients with HER2-positive metastatic breast cancer
On Apr. 17, 2020, as part of Project Orbis, the U.S. Food and Drug Administration (FDA) approved Seagen’s…
FDA granted ExThera’s Seraph-100 blood filter Emergency Use Authorization for treatment of COVID-19 after promising results in europe and U.S.
On Apr. 17, 2020, after promising COVID-19 treatments in Germany, France, Italy, Spain and the U.S,, ExThera Medical’s…
Dynavax and Sinovac announced collaboration to develop a Coronavirus (COVID-19) vaccine
On Apr. 16, 2020, Dynavax and Sinovac Biotech, a leading provider of biopharmaceutical products in China, announced a…
FDA accepted for Priority Review Biologics License Application for REGN-EB3 to treat Ebola
On Apr. 16, 2020, Regeneron announced the FDA has accepted for Priority Review a new Biologics License Application…
Atossa Therapeutics launched COVID-19 HOPE drug development program
On Apr. 16, 2020, Atossa Therapeutics announced a new drug development program called COVID-19 HOPE. The program used…
FDA approved initiation of Humanigen’s phase III study of lenzilumab in COVID-19 patients
On Apr. 15, 2020, Humanigen announced that U.S. Food and Drug Administration (FDA) had given permission to commence…
FDA authorized first-of-its-kind low-cost ventilator developed by University of Minnesota
On Apr. 15, 2020, the U.S. Food and Drug Administration (FDA) authorized the production and use of a…
Orthoﾒs total antibody test for COVID-19 received Emergency Use Authorization from FDA
On Apr. 15, 2020, the FDA announced it granted Emergency Use Authorization to Ortho Clinical Diagnosticsﾒ total antibody…
Todos Medical received medical importer status with U.S. FDA
On Apr. 15, 2020, Todos Medical announced the FDA has accepted Todos Medical’s application for Medical Device Establishment…
Chembio Diagnostics received Emergency Use Authorization for DPP COVID-19 s for IgG and IgM antibodies
On Apr. 15, 2020, Chembio Diagnostics announced receipt of FDA Emergency Use Authorization (EUA) for its DPP COVID-19…
NantKwest and ImmunityBio announced therapeutics and vaccines for combatting COVID-19
On Apr. 14, 2020, NantKwest and ImmunityBio announced discussions with the FDA for vaccines and therapeutics to combat…
FDA approved first therapy for children with debilitating and disfiguring rare disease
On Apr. 13, 2020, the U.S. Food and Drug Administration (FDA) announced that given the increased demand for…
Pluristem treated first COVID-19 patient in US under FDA single patient expanded access program
On Apr. 13, 2020, Pluristem Therapeutics announced it has treated its first patient suffering from COVID-19 complications in…
FDA authorized Athersys to initiate pvotal clinical trial evaluating MultiStemﾮ cell therapy in patients with COVID-19 induced ARDS
On Apr. 13, 2020, Athersys announced the FDA has authorized the Company to initiate a Phase 2/3 pivotal…
Terumo BCT and Marker Therapeutics received FDA Emergency Use Authorization to treat acute respiratory failure in COVID-19 patients
On Apr. 10, 2020, Terumo BCT and Marker Therapeutics announced the FDA issued an Emergency Use Authorization (EUA)…
FDA approved first therapy for children with debilitating and disfiguring rare disease
On Apr. 10, 2020, the FDA approved AstraZeneca ‘s Koselugo (selumetinib) for treatment of pediatric patients, 2 years…
STERIS announced decontamination solution for rrespiratory masks
On Apr. 10, 2020, STERIS announced that the FDA issued an Emergency Use Authorization (EUA) for respirator decontamination….