Orthoï¾’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 Diagnosticsï¾’ 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 FDA announced that given the increased demand for chloroquine phosphate and hydroxychloroquine sulfate,…
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 MultiStemï¾® 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…
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….
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)…
Positive data generated by Biosig subsidiary ViralClear on Covid-19 Coronavirus published in bioRxiv
On Apr. 9, 2020, BioSig Technologies announced that an article titled “The IMPDH inhibitor merimepodib suppresses SARS-COV-2 replications”…
Chembio Diagnostics and Stony Brook Medicine collaborated to identify Coronavirus survivors
On Apr. 9, 2020, Chembio Diagnostics has been selected for use in a Stony Brook Medicine effort to…
Abbott FreeStyleï¾® Libre 14 Day System available in US for hospitalized patients with diabetes during COVID-19 pandemic
On Apr. 8, 2020, Abbott announced that the FreeStyle Libre 14 day system, a continuous glucose monitoring (CGM)…
Bellerophon Therapeutics submitted investigational NDA to study INOpulseï¾® inhaled nitric oxide for treatment of COVID-19
On Apr. 8, 2020, Bellerophon Therapeutics announced submission of an Investigational New Drug (IND) application to the FDA…
FDA approved BRAFTOVIï¾® (Encorafenib) in combination with Cetuximab for treatment of BRAFV600E-mutant metastatic colorectal cancer
On Apr. 9, 2020, Pfizer announced that the FDA had approved BRAFTOVIï¾® (encorafenib) in combination with cetuximab (marketed…
InBios received EUA for its Smart Detect SARS-CoV-2 rRT-PCR Kit for detection of virus causing COVID-19
On Apr. 8, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the FDA for…
Karyopharm to evaluate low dose Selinexor as potential treatment for hospitalized patients with COVID-19
On Apr. 7, 2020, Karyopharm Therapeutics announced plans to initiate a global randomized clinical trial for low dose…
Cumberland Pharma expanded availability of Vaprisol to treat Hyponatremia for critical care COVID-19 patients
On Apr. 7, 2020, Cumberland Pharma announced an initiative to increase availability of Vaprisol (conivaptan hydrochloride) injection for…
FDA cleared Mesoblast IND for remestemcel use in COVID-19 ARDS patients
On Apr. 6, 2020, Mesoblast announced it had received clearance from the U.S. Food and Drug Administration (FDA)…
INOVIO initiated phase 1 clinical trial of its COVID-19 vaccine and plans first dose
On Apr. 6, 2020, Inovio Pharma announced the FDA has accepted the company’s Investigational New Drug application for…
OraSure Technologies received BARDA contract for Rapid Oral Fluid Pan-SARS-Coronavirus in-home self-test
On Apr. 6, 2020, OraSure Technologies announced it has been awarded a $710,310 contract from the Biomedical Advanced…
Luminex received FDA Emergency Use Authorization for ARIES SARS-CoV-2 assay to detect virus responsible for COVID-19 disease
On Apr. 6, 2020, Luminex announced announced that the FDA has issued an Emergency Use Authorization for its…
Mayo Clinic named national site for Convalescent Plasma Expanded Access Program
On Apr. 3, 2020, the FDA announced that the Mayo Clinic Mayo Clinic will be the lead institution…
BD, BioGX announced FDA Emergency Use Authorization for new COVID-19 diagnostic for use in U.S.
On Apr. 3, 2020, BD (Becton, Dickinson) and BioGX announced that the U.S. Food and Drug Administration (FDA)…
XBiotech and BioBridge Global collaborate on FDA program to develop potential COVID-19 antibody-based treatment
On Apr. 3, 2020, XBiotech and BioBridge Global announced a collaboration to participate in a FDA investigational program…
FDA approved Emergency IND Use of Humanigen’s lenzilumab for compassionate use in COVID-19 patients
On Apr. 2, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to the U.S….
Incyte initiated phase 3 clinical trial of Ruxolitinib (Jakafi) as treatment for patients with COVID-19 cytokine storm
On Apr. 2, 2020, Incyte announced it was working with the U.S. Food and Drug Administration (FDA) to…
Luminex received BARDA contract to support development of second, rapid SARS-CoV-2 test
On Mar. 31, 2020, Luminex announced it had received $642,450 in funding from the Biomedical Advanced Research and…
Medtronic shared ventilation design specifications to accelerate efforts to increase global ventilator production
On Mar. 30, 2020 Medtronic announced it was publicly sharing the design specifications for the Puritan Bennett 560…
Humanigen partnered with CTI for planned phase III study for lenzilumab for coronavirus treatment
On Mar. 30, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to the FDA…