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Home / FDA - Page 22

FDA

LabCorp COVID-19 at-home test kit received FDA Emergency Use Authorization
COVID-19 | FDA | Life Science History

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…

Read More LabCorp COVID-19 at-home test kit received FDA Emergency Use AuthorizationContinue

Todos Medical announced FDA Emergency Use Authorization allowed for Gnomegen COVID-19 PCR test kits
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…

Read More Todos Medical announced FDA Emergency Use Authorization allowed for Gnomegen COVID-19 PCR test kitsContinue

Novartis announced plan to initiate clinical study of Jakavi in severe COVID-19 patients
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

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…

Read More Novartis announced plan to initiate clinical study of Jakavi in severe COVID-19 patientsContinue

Alexion announced plans to initiate phase 3 study of ULTOMIRISᆴ (ravulizumab-cwvz) in hospitalized patients with severe COVID-19
COVID-19 | FDA | Life Science History

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)…

Read More Alexion announced plans to initiate phase 3 study of ULTOMIRISᆴ (ravulizumab-cwvz) in hospitalized patients with severe COVID-19Continue

Screening of 11,552 compounds identified Innovation Pharma’s Brilacidin as promising Potential inhibitors of novel Coronavirus COVID-19
COVID-19 | FDA | Life Science History

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…

Read More Screening of 11,552 compounds identified Innovation Pharma’s Brilacidin as promising Potential inhibitors of novel Coronavirus COVID-19Continue

Atossa Therapeutics submitted Clinical Investigation approval to FDA for launch of COVID-19 HOPE study
COVID-19 | FDA | Life Science History

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…

Read More Atossa Therapeutics submitted Clinical Investigation approval to FDA for launch of COVID-19 HOPE studyContinue

FDA approved first new drug under international collaboration for patients with HER2-positive metastatic breast cancer
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…

Read More FDA approved first new drug under international collaboration for patients with HER2-positive metastatic breast cancerContinue

FDA granted ExThera’s Seraph-100 blood filter Emergency Use Authorization for treatment of COVID-19 after promising results in europe and U.S.
COVID-19 | FDA | Medical Device | Therapeutics

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…

Read More FDA granted ExThera’s Seraph-100 blood filter Emergency Use Authorization for treatment of COVID-19 after promising results in europe and U.S.Continue

Dynavax and Sinovac announced collaboration to develop a Coronavirus (COVID-19) vaccine
COVID-19 | FDA | Life Science History

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…

Read More Dynavax and Sinovac announced collaboration to develop a Coronavirus (COVID-19) vaccineContinue

FDA accepted for Priority Review Biologics License Application for REGN-EB3 to treat Ebola
FDA | Life Science History

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…

Read More FDA accepted for Priority Review Biologics License Application for REGN-EB3 to treat EbolaContinue

Atossa Therapeutics launched COVID-19 HOPE drug development program
Biotechnology | COVID-19 | FDA | Life Science History | Therapeutics

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…

Read More Atossa Therapeutics launched COVID-19 HOPE drug development programContinue

FDA approved initiation of Humanigen’s phase III study of lenzilumab in COVID-19 patients
COVID-19 | FDA | Life Science History

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…

Read More FDA approved initiation of Humanigen’s phase III study of lenzilumab in COVID-19 patientsContinue

FDA authorized first-of-its-kind low-cost ventilator developed by University of Minnesota
COVID-19 | FDA | Life Science History | Medical Device

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…

Read More FDA authorized first-of-its-kind low-cost ventilator developed by University of MinnesotaContinue

Orthoメs total antibody test for COVID-19 received Emergency Use Authorization from FDA
COVID-19 | FDA | Life Science History

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…

Read More Orthoメs total antibody test for COVID-19 received Emergency Use Authorization from FDAContinue

Todos Medical received medical importer status with U.S. FDA
COVID-19 | FDA | Medical Device

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…

Read More Todos Medical received medical importer status with U.S. FDAContinue

Chembio Diagnostics received Emergency Use Authorization for DPP COVID-19 s for IgG and IgM antibodies
COVID-19 | FDA | Life Science History

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…

Read More Chembio Diagnostics received Emergency Use Authorization for DPP COVID-19 s for IgG and IgM antibodiesContinue

NantKwest and ImmunityBio announced therapeutics and vaccines for combatting COVID-19
COVID-19 | FDA | Life Science History

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…

Read More NantKwest and ImmunityBio announced therapeutics and vaccines for combatting COVID-19Continue

FDA approved first therapy for children with debilitating and disfiguring rare disease
Biotechnology | FDA | Rare Disease | Therapeutics

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…

Read More FDA approved first therapy for children with debilitating and disfiguring rare diseaseContinue

Pluristem treated first COVID-19 patient in US under FDA single patient expanded access program
COVID-19 | FDA | Life Science History

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…

Read More Pluristem treated first COVID-19 patient in US under FDA single patient expanded access programContinue

FDA authorized Athersys to initiate pvotal clinical trial evaluating MultiStemᆴ cell therapy in patients with COVID-19 induced ARDS
COVID-19 | FDA | Life Science History

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…

Read More FDA authorized Athersys to initiate pvotal clinical trial evaluating MultiStemᆴ cell therapy in patients with COVID-19 induced ARDSContinue

FDA approved first therapy for children with debilitating and disfiguring rare disease
FDA | Life Science History

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…

Read More FDA approved first therapy for children with debilitating and disfiguring rare diseaseContinue

STERIS announced decontamination solution for rrespiratory masks
FDA | Life Science History

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….

Read More STERIS announced decontamination solution for rrespiratory masksContinue

Terumo BCT and Marker Therapeutics received FDA Emergency Use Authorization to treat acute respiratory failure in COVID-19 patients
COVID-19 | FDA | Life Science History

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)…

Read More Terumo BCT and Marker Therapeutics received FDA Emergency Use Authorization to treat acute respiratory failure in COVID-19 patientsContinue

Positive data generated by Biosig subsidiary ViralClear on Covid-19 Coronavirus published in bioRxiv
COVID-19 | Diagnostics | FDA | Infectious Disease | Therapeutics

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”…

Read More Positive data generated by Biosig subsidiary ViralClear on Covid-19 Coronavirus published in bioRxivContinue

Chembio Diagnostics and Stony Brook Medicine collaborated to identify Coronavirus survivors
COVID-19 | FDA | Life Science History

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…

Read More Chembio Diagnostics and Stony Brook Medicine collaborated to identify Coronavirus survivorsContinue

Abbott FreeStyleᆴ Libre 14 Day System available in US for hospitalized patients with diabetes during COVID-19 pandemic
COVID-19 | FDA | Life Science History

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)…

Read More Abbott FreeStyleᆴ Libre 14 Day System available in US for hospitalized patients with diabetes during COVID-19 pandemicContinue

Bellerophon Therapeutics submitted investigational NDA to study INOpulseᆴ inhaled nitric oxide for treatment of COVID-19
COVID-19 | FDA | Life Science History

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…

Read More Bellerophon Therapeutics submitted investigational NDA to study INOpulseᆴ inhaled nitric oxide for treatment of COVID-19Continue

FDA approved BRAFTOVIᆴ (Encorafenib) in combination with Cetuximab for treatment of BRAFV600E-mutant metastatic colorectal cancer
FDA | Life Science History

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…

Read More FDA approved BRAFTOVIᆴ (Encorafenib) in combination with Cetuximab for treatment of BRAFV600E-mutant metastatic colorectal cancerContinue

InBios received EUA for its Smart Detect SARS-CoV-2 rRT-PCR Kit for detection of virus causing COVID-19
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…

Read More InBios received EUA for its Smart Detect SARS-CoV-2 rRT-PCR Kit for detection of virus causing COVID-19Continue

Karyopharm to evaluate low dose Selinexor as potential treatment for hospitalized patients with COVID-19
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…

Read More Karyopharm to evaluate low dose Selinexor as potential treatment for hospitalized patients with COVID-19Continue

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