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…
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…
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….
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…
Biotechnology | COVID-19 | Diagnostics | FDA
CIRM approved $5 Million in emergency funding for COVID-19 research
On Mar. 27, 2020, in response to the crisis caused by the COVID-19 virus in California and around…
Humanigen submitted phase III protocol synopsis to FDA for lenzilumab for Coronavirus treatment
On Mar. 27, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to U.S. Food…
COVID-19 | Diagnostics | FDA | Medical Device
Luminex receives FDA Emergency Use Authorization for NxTAG CoV Extended Panel to detect SARS-CoV-2 Virus
On Mar. 27, 2020, Luminex announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization…
Military scientists, engineers develop ventilator prototype
On Mar. 27, 2020, scientists and engineers at Naval Surface Warfare Center Panama City Division announced development of…
Abbott launched molecular point-of-care test to detect novel Coronavirus in as Little as five minutes
On Mar. 27, 2020, Abbott announced the FDA has issued Emergency Use Authorization (EUA) for the fastest available…
Abbott launched molecular point-of-care test to detect novel Coronavirus in as little as five minutes
On Mar. 27, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for the fastest…
FDA supports transparency and collaboration in drug approval process as clinical data summary pilot concluded
On Mar. 26, 2020, the FDA reported that it had become increasingly clear that the FDA needed to…
COVID-19 | Diagnostics | FDA
FDA provided Emergency Use Authorization to PerkinElmer for COVID-19 testing
On Mar. 24, 2020, PerkinElmer announced the U.S. Food and Drug Administration (FDA) had provided Emergency Use Authorization…
Biotechnology | COVID-19 | Diagnostics | FDA
bioMerieux received FDA Emergency Use Authorization for BIOFIRE COVID-19 test
On Mar. 24, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, had…
Mesa Biotech received Emergency Use Authorization from FDA for 30 minute point ofcCare molecular COVID-19 test
On Mar. 24, 2020, Mesa Biotech announced it had received Emergency Use Authorization (EUA) from the FDA for…
Windtree announced clinical study of lung injury treatment in COVID-19 patients with its KL4 surfactant therapy
On Mar. 24, 2020, Windtree Therapeutics announced it will study its proprietary KL4 surfactant to potentially mitigate the…
T2 Biosystems announced worldwide licensing agreement of COVID-19, novel Coronavirus assay
On Mar. 24, 2020, T2 Biosystems announced it has entered into a worldwide licensing agreement for a rapid…
FDA Issues first Emergency Use Authorization for Point of Care Diagnostic
On Mar. 21, 2020, the FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for…
FDA allowed expanded use of devices to monitor patients’ vital signs remotely
On Mar. 20, 2020, the U.S. Food and Drug Administration (FDA) issued a new policy that allowed manufacturers…
FDA granted Bellerophon emergency expanded access for INOpulse for treatment of COVID-19 virus
On Mar. 20, 2020, Bellerophon Therapeutics announced the U.S. Food and Drug Administration (FDA) had granted emergency expanded…
Abbott received FDA Emergency Use Authorization and launches test to detect novel Coronavirus
On Mar. 19, 2020, Abbott announced the FDA has issued Emergency Use Authorization (EUA) for the company’s molecular…
Roche initiated phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
On Mar. 19, 2020, Roche announced it was working with the U.S. Food & Drug Administration (FDA) to…
FDA approved Epclusa (Sofosbuvir/Velpatasvir) for children with Chronic Hepatitis C infection
On Mar. 19, 2020, Gilead Sciences announced the U.S. Food and Drug Administration (FDA) had approved a supplemental…
Mylan ramped up U.S. manufacturing of hydroxychloroquine sulfate tablets to meet potential COVID-19 patient needs
On Mar. 19, 2020, Mylan announced it had restarted production of hydroxychloroquine sulfate tablets at its West Virginia…