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…
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…
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…
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…
Abbott received FDA Emergency Use Authorization and launched test to detect novel Coronavirus
On Mar. 18, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for the company’s…
Biotechnology | COVID-19 | FDA | Therapeutics
Mateon to develop its OT-101, a phase 3 clinical drug candidate against COVID-19
On Mar. 18, 2020, Mateon Therapeutics reported significant progress in deploying its phase 3 clinical asset, OT-101, against…
Eli Lilly and Indiana State Department of Health partnered to accelerate COVID-19 testing using Lilly Research Laboratories
On Mar. 18, 2020, Eli Lilly announced its scientists were partnering with the Indiana State Department of Health…
Biotechnology | COVID-19 | Diagnostics | FDA
Quidel received Emergency Use Authorization for molecular COVID-19 diagnostic assay
On Mar. 17, 2020, Quidel Corp. announced it had received Emergency Use Authorization (EUA) from the U.S. Food…
Latest FDA guidance allows distribution of SARS-CoV-2 serology tests for diagnostic use
On Mar. 17, 2020, BioMedomics announced it will be able to distribute their COVID-19 IgM-IgG Antibody Rapid Test…
Todos Medical announced Coronavirus Nucleic Acid Buccal Testing Kit distribution agreement with 3D BioMed
On Mar. 17, 2020, Todos Medical announced a non-exclusive distribution agreement with 3D Biomedicine Science & Technology, a…
Aimmune announced first U.S. patients treated with PALFORZIA, the first treatment for peanut allergy
On Mar. 16, 2020, Aimmune Therapeutics announced that the first patients in the U.S. were being treated with…
Biotechnology | COVID-19 | Diagnostics | FDA
Hologic’s molecular test for the novel Coronavirus, SARS-CoV-2, receives FDA Emergency Use Authorization
On Mar. 16, 2020, Hologic announced the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization…
Biotechnology | COVID-19 | Diagnostics | FDA
BD, BioGX announced FDA Emergency Use Authorization submissions for new COVID-19 diagnostics for use in U.S.
On Mar. 16, 2020, BD (Becton, Dickinson and Company) announced the companies had submitted Emergency Use Authorization requests…
Roche announced FDA Emergency Use Authorization and availablabilityof cobas SARS-CoV-2 detection test
On Mar. 13, 2020, Roche announced the FDA has issued an Emergency Use Authorization for the cobasﾮ SARS-CoV-2…
FDA issued Emergency Use Authorization to Thermo Fisher Scientific for diagnostic test for COVID-19
On Mar. 13, 2020, Thermo Fisher Scientific announced the FDA has issued an emergency use authorization (EUA) for…