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…
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…
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)…
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…
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 FreeStyleﾮ 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 INOpulseﾮ 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 BRAFTOVIﾮ (Encorafenib) in combination with Cetuximab for treatment of BRAFV600E-mutant metastatic colorectal cancer
On Apr. 9, 2020, Pfizer announced that the FDA had approved BRAFTOVIﾮ (encorafenib) in combination with cetuximab (marketed…
Biotechnology | COVID-19 | Diagnostics | FDA
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…
Biotechnology | COVID-19 | FDA | Therapeutics
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…
COVID-19 | FDA | Therapeutics
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…
COVID-19 | FDA | Therapeutics
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)…
COVID-19 | FDA | Infectious Disease | Vaccine
INOVIO initiated phase 1 clinical trial of its COVID-19 vaccine
On Apr. 6, 2020, Inovio Pharma announced the U.S. Food and Drug Administration (FDA) had accepted the company’s…
OraSure Technologies received BARDA contract for Rapid Oral Fluid Pan-SARS-Coronavirus in-home self-test
On Apr. 6, 2020, OraSure Technologies announced it had 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…
COVID-19 | Diagnostics | FDA
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…
COVID-19 | Diagnostics | FDA
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….
Biotechnology | COVID-19 | FDA | Therapeutics
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…
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…
Bellerophon Therapeutics announced first patient treated with INOpulse inhaled nitric oxide therapy for COVID-19
On Mar. 30, 2020, Bellerophon Therapeutics announced that expanded access treatment with the INOpulse inhaled nitric oxide system…
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…
Biotechnology | COVID-19 | FDA | Therapeutics
FDA issued EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products from Strategic National Stockpile to be distributed
On Mar. 28, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to…