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Home / FDA - Page 17

FDA

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

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

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

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

Data from Corvus phase 1 study of CPI-006 continued to support its potential as treatment for COVID-19
Biotechnology | COVID-19 | FDA | Pharmaceutical

Data from Corvus phase 1 study of CPI-006 continued to support its potential as treatment for COVID-19

On Oct. 5, 2020, Corvus Pharmaceuticals announced that it has initiated a Phase 1 study to investigate a…

Read More Data from Corvus phase 1 study of CPI-006 continued to support its potential as treatment for COVID-19Continue

FDA approved drug combination for treating mesothelioma
FDA | Life Science History

FDA approved drug combination for treating mesothelioma

On Oct. 1, 2020, the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment…

Read More FDA approved drug combination for treating mesotheliomaContinue

LabCorp COVID-19 molecular test innovation received FDA authorization
COVID-19 | FDA | Life Science History

LabCorp COVID-19 molecular test innovation received FDA authorization

On Oct. 2, 2020, LabCorp announced that it had received an Emergency Use Authorization (EUA) from the FDA…

Read More LabCorp COVID-19 molecular test innovation received FDA authorizationContinue

Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of two
Disease | FDA

Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of two

On Sept. 29, 2020, Oxford Immunotec announced that it had received clearance from the FDA to amend the…

Read More Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of twoContinue

Windtree announced FDA acceptance of IND application for phase 2 clinical trial studying KL4 Surfactant in acute lung injury in adults with COVID-19
COVID-19 | FDA | Life Science History

Windtree announced FDA acceptance of IND application for phase 2 clinical trial studying KL4 Surfactant in acute lung injury in adults with COVID-19

On Sept. 29, 2020, Windtree Therapeutics announced that FDA had accepted its Investigational New Drug application for a…

Read More Windtree announced FDA acceptance of IND application for phase 2 clinical trial studying KL4 Surfactant in acute lung injury in adults with COVID-19Continue

Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 assay
COVID-19 | FDA | Life Science History

Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 assay

On Sept. 28, 2020, Hologic announced that its Panther Fusionᆴ SARS-CoV-2 assay had received Emergency Use Authorization (EUA)…

Read More Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 assayContinue

INOVIO reported FDA partial clinical hold for planned phase 2/3 trial of COVID-19 vaccine candidate INO-4800
Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine

INOVIO reported FDA partial clinical hold for planned phase 2/3 trial of COVID-19 vaccine candidate INO-4800

On Sept. 28, 2020, INOVIO announced the U.S. Food and Drug Administration (FDA) had notified the company that…

Read More INOVIO reported FDA partial clinical hold for planned phase 2/3 trial of COVID-19 vaccine candidate INO-4800Continue

FDA took actions to help lower US prescription drug prices
FDA | Life Science History

FDA took actions to help lower US prescription drug prices

On Sept. 24, 2020, the U.S. Department of Health and Human Services and the U.S. Food and Drug…

Read More FDA took actions to help lower US prescription drug pricesContinue

FDA authorized first point-of-care antibody test for COVID-19
COVID-19 | FDA | Life Science History

FDA authorized first point-of-care antibody test for COVID-19

On Sept. 23, 2020, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care…

Read More FDA authorized first point-of-care antibody test for COVID-19Continue

FDA launched the Digital Health Center of Excellence
FDA | Life Science History

FDA launched the Digital Health Center of Excellence

On Sept. 22, 2020, the FDA announced it had launched the Digital Health Center of Excellence within the…

Read More FDA launched the Digital Health Center of ExcellenceContinue

Roche launched new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
FDA | Life Science History

Roche launched new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines

On Sept. 18, 2020, Roche announced the launch of its Elecsysᆴ Anti-SARS-CoV-2 S antibody test for markets accepting…

Read More Roche launched new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccinesContinue

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