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Home / FDA - Page 17

FDA

Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancer
Biotechnology | FDA | Oncology | Therapeutics

Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancer

On Nov. 13, 2020, Agilent Technologies announced it had received U.S. Food and Drug Administration (FDA) approval for…

Read More Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancerContinue

Wren Laboratories launched saliva-based PCR COVID-19 test
Biotechnology | COVID-19 | Diagnostics | FDA

Wren Laboratories launched saliva-based PCR COVID-19 test

On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…

Read More Wren Laboratories launched saliva-based PCR COVID-19 testContinue

EUROIMMUN launched quantitative ELISA to measure SARS-CoV-2 antibodies against viral S1 protein
FDA | Life Science History

EUROIMMUN launched quantitative ELISA to measure SARS-CoV-2 antibodies against viral S1 protein

On Nov. 9, 2020, PerkinElmer announced that EUROIMMUN, a PerkinElmer company, had launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG)…

Read More EUROIMMUN launched quantitative ELISA to measure SARS-CoV-2 antibodies against viral S1 proteinContinue

Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19
COVID-19 | FDA | Life Science History

Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19

On Nov. 9, 2020, the FDA granted Emergency Use Authorization (EUA) for Eli Lilly’s investigational neutralizing antibody bamlanivimab…

Read More Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19Continue

FDA authorized first test that detected neutralizing antibodies from recent or prior SARS-CoV-2 infection
FDA | Life Science History

FDA authorized first test that detected neutralizing antibodies from recent or prior SARS-CoV-2 infection

On Nov. 6, 2020, the FDA authorized the first serology test that detected neutralizing antibodies from recent or…

Read More FDA authorized first test that detected neutralizing antibodies from recent or prior SARS-CoV-2 infectionContinue

OraSure’s DNA Genotek subsidiary received FDA EUA for its ORAcollect-RNA saliva collectiondevice for SARS CoV-2
Biotechnology | COVID-19 | FDA

OraSure’s DNA Genotek subsidiary received FDA EUA for its ORAcollect-RNA saliva collectiondevice for SARS CoV-2

On Nov. 3, 2020, OraSure Technologies announced its DNA Genotek subsidiary has received Emergency Use Authorization from the…

Read More OraSure’s DNA Genotek subsidiary received FDA EUA for its ORAcollect-RNA saliva collectiondevice for SARS CoV-2Continue

Innovation Pharmaceuticals received pre-IND response from FDA on COVID-19 trial
COVID-19 | FDA | Life Science History

Innovation Pharmaceuticals received pre-IND response from FDA on COVID-19 trial

On Nov. 2, 2020, Innovation Pharma announced receipt of written feedback from the FDA that is in general…

Read More Innovation Pharmaceuticals received pre-IND response from FDA on COVID-19 trialContinue

OncoSec announced FDA clearance of IND application for phase 1 clinical trial of CORVax12 vaccine candidate for COVID-19
FDA | Life Science History

OncoSec announced FDA clearance of IND application for phase 1 clinical trial of CORVax12 vaccine candidate for COVID-19

On Oct. 29, 2020, OncoSec Medical announced that the FDA had approved the Investigational New Drug (IND) application…

Read More OncoSec announced FDA clearance of IND application for phase 1 clinical trial of CORVax12 vaccine candidate for COVID-19Continue

AquaBounty announced Mayfield, Kentucky as location for planned 10,000 metric ton salmon farm
Biotechnology | FDA | Marine Science

AquaBounty announced Mayfield, Kentucky as location for planned 10,000 metric ton salmon farm

On Oct. 29, 2020, AquaBounty Technologies announced that it had identified Mayfield, Kentucky as the potential location for…

Read More AquaBounty announced Mayfield, Kentucky as location for planned 10,000 metric ton salmon farmContinue

PerkinElmer COVID-19 test kit receives FDA Emergency Use Authorization for sample pooling
COVID-19 | FDA | Life Science History

PerkinElmer COVID-19 test kit receives FDA Emergency Use Authorization for sample pooling

On Oct. 29, 2020, PerkinElmer announced that the FDA had issued Emergency Use Authorization (EUA) to allow sample…

Read More PerkinElmer COVID-19 test kit receives FDA Emergency Use Authorization for sample poolingContinue

Emulate collaborated with FDA to apply lung-chip to evaluate safety of COVID-19 vaccines
COVID-19 | FDA | Life Science History

Emulate collaborated with FDA to apply lung-chip to evaluate safety of COVID-19 vaccines

On Oct. 29, 2020, Emulate announced that it had entered into a Cooperative Research and Development Agreement (CRADA)…

Read More Emulate collaborated with FDA to apply lung-chip to evaluate safety of COVID-19 vaccinesContinue

Lilly announced agreement with US government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab to fight COVID-19
Biotechnology | COVID-19 | FDA | Therapeutics

Lilly announced agreement with US government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab to fight COVID-19

On Oct. 28, 2020, Eli Lilly announced an initial agreement with the U.S. government to supply 300,000 vials…

Read More Lilly announced agreement with US government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab to fight COVID-19Continue

Nektar Therapeutics announced phase 1b clinical study to evaluate empegaldesleukin for treatment of patients with COVID-19
COVID-19 | FDA | Life Science History

Nektar Therapeutics announced phase 1b clinical study to evaluate empegaldesleukin for treatment of patients with COVID-19

On Oct. 27, 2020, Nektar Therapeutics announced that it has received FDA clearance for an Investigational New Drug…

Read More Nektar Therapeutics announced phase 1b clinical study to evaluate empegaldesleukin for treatment of patients with COVID-19Continue

ContraFect initiated expanded access to Exebacase for treatment of MRSA bloodstream infections in COVID-19 patients
COVID-19 | FDA | Life Science History

ContraFect initiated expanded access to Exebacase for treatment of MRSA bloodstream infections in COVID-19 patients

On Oct. 26, 2020, ContraFect announced that it had initiated an expanded access program to provide exebacase for…

Read More ContraFect initiated expanded access to Exebacase for treatment of MRSA bloodstream infections in COVID-19 patientsContinue

Global clinical trials of COVID-19 vaccine resumed
FDA | Life Science History

Global clinical trials of COVID-19 vaccine resumed

On Oct. 23, 2020, the U.S. FDA authorised a restart of clinical trials of the ChAdOx1 nCov-2019 Oxford…

Read More Global clinical trials of COVID-19 vaccine resumedContinue

FDA approved first treatment for COVID-19
COVID-19 | FDA | Life Science History

FDA approved first treatment for COVID-19

On Oct. 22, 2020, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric…

Read More FDA approved first treatment for COVID-19Continue

Moderna completed enrollment of phase 3 COVE study of mRNA vaccine against COVID-19
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna completed enrollment of phase 3 COVE study of mRNA vaccine against COVID-19

On Oct. 22, 2020, Moderna announced that it had completed enrollment of 30,000 participants for the Phase 3…

Read More Moderna completed enrollment of phase 3 COVE study of mRNA vaccine against COVID-19Continue

FDA approved Gilead’s antiviral Veklury (remdesivir) for treatment of COVID-19
Biotechnology | COVID-19 | FDA | Therapeutics

FDA approved Gilead’s antiviral Veklury (remdesivir) for treatment of COVID-19

On Oct. 22, 2020, Gilead Sciences announced that the FDA had approved the antiviral drug Veklury (remdesivir) for…

Read More FDA approved Gilead’s antiviral Veklury (remdesivir) for treatment of COVID-19Continue

FDA authorized phase 1 trial of ImmunityBioメs novel COVID-19 vaccine candidate hAd5 to drive T cell and antibody immunity
COVID-19 | FDA | Life Science History

FDA authorized phase 1 trial of ImmunityBioメs novel COVID-19 vaccine candidate hAd5 to drive T cell and antibody immunity

On Oct. 15, 2020, ImmunityBio announced it had received authorization from the FDA to begin a Phase I…

Read More FDA authorized phase 1 trial of ImmunityBioメs novel COVID-19 vaccine candidate hAd5 to drive T cell and antibody immunityContinue

Biotechnology | FDA | Therapeutics

FDA approved first treatment for Ebola virus

On Oct. 14, 2020, the FDA approved Regeneron Pharmaceutical’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three…

Read More FDA approved first treatment for Ebola virusContinue

Vaxart announced positive hamster challenge study data for its oral COVID-19 vaccine
COVID-19 | FDA | Life Science History

Vaxart announced positive hamster challenge study data for its oral COVID-19 vaccine

On Oct. 14, 2020, Vaxart announced that the FDA had completed its review of the Companyメs Investigational New…

Read More Vaxart announced positive hamster challenge study data for its oral COVID-19 vaccineContinue

Tevogen Bio submitted IND for T cell treatment in COVID-19
COVID-19 | FDA | Life Science History

Tevogen Bio submitted IND for T cell treatment in COVID-19

On Oct. 14, 2020, Tevogen Bio announced that its Investigational New Drug (IND) application to develop a COVID-19…

Read More Tevogen Bio submitted IND for T cell treatment in COVID-19Continue

Biotechnology | FDA | Therapeutics

Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)

On Oct. 14, 2020, Regeneron announced that the FDA had approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the…

Read More Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)Continue

Roche launched laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
FDA | Life Science History

Roche launched laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

On Oct. 13, 2020, Roche announced that it intended to launch a high-volume SARS-CoV-2 Antigen test as an…

Read More Roche launched laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patientsContinue

New CAR T-Cell therapy approved and available at Roswell Park for lymphoma patients
FDA | Life Science History

New CAR T-Cell therapy approved and available at Roswell Park for lymphoma patients

On Oct. 13, 2020, Roswell Park Comprehensive Cancer Center announced that it had been approved to administer the…

Read More New CAR T-Cell therapy approved and available at Roswell Park for lymphoma patientsContinue

FDA awarded grants to fund clinical trials to advance development of products for treatment of rare diseases
FDA | Life Science History | U.S. Congress

FDA awarded grants to fund clinical trials to advance development of products for treatment of rare diseases

On Oct. 8, 2020, the FDA announced that it had awarded six new clinical trial research grants to…

Read More FDA awarded grants to fund clinical trials to advance development of products for treatment of rare diseasesContinue

Abbott’s released ID NOW COVID-19 interim clinical study results to provide facts on clinical performance
Biotechnology | COVID-19 | Diagnostics | FDA

Abbott’s released ID NOW COVID-19 interim clinical study results to provide facts on clinical performance

On Oct. 7, 2020, in a continuing effort to provide the facts about ID NOW to support public…

Read More Abbott’s released ID NOW COVID-19 interim clinical study results to provide facts on clinical performanceContinue

FDA broadly supported Oragenicsメ pre-IND development program for its SARS-CoV-2 vaccine
FDA | Life Science History

FDA broadly supported Oragenicsメ pre-IND development program for its SARS-CoV-2 vaccine

On Oct. 6, 2020, Oragenics announced receipt of feedback to its Type B Pre-IND Meeting Request from the…

Read More FDA broadly supported Oragenicsメ pre-IND development program for its SARS-CoV-2 vaccineContinue

FDA amended EUA for Hologicメs Aptima SARS-CoV-2 assay to Include COVID-19 testing of asymptomatic individuals
COVID-19 | FDA | Life Science History

FDA amended EUA for Hologicメs Aptima SARS-CoV-2 assay to Include COVID-19 testing of asymptomatic individuals

On Oct. 6, 2020, Hologic announced that its Aptimaᆴ SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA)…

Read More FDA amended EUA for Hologicメs Aptima SARS-CoV-2 assay to Include COVID-19 testing of asymptomatic individualsContinue

FDA awarded contract to Stanford University to perform in-depth analysis of tissue samples to learn how SARS-CoV-2 causes COVID-19
COVID-19 | FDA | Life Science History

FDA awarded contract to Stanford University to perform in-depth analysis of tissue samples to learn how SARS-CoV-2 causes COVID-19

On Oct. 5, 2020, the FDA awarded a research contract to the Stanford University School of Medicine to…

Read More FDA awarded contract to Stanford University to perform in-depth analysis of tissue samples to learn how SARS-CoV-2 causes COVID-19Continue

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