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Home / FDA - Page 18

FDA

AXIM Biotechnologies filed Emergency Use Authorization with COVID-19 rapid diagnostic test for neutralizing antibodies
COVID-19 | FDA | Therapeutics

AXIM Biotechnologies filed Emergency Use Authorization with COVID-19 rapid diagnostic test for neutralizing antibodies

On Sept. 16, 2020, AXIM Biotechnologies announced that it had filed an Emergency Use Authorization (EUA) application with…

Read More AXIM Biotechnologies filed Emergency Use Authorization with COVID-19 rapid diagnostic test for neutralizing antibodiesContinue

FDA contracted with global partners to analyze coronavirus samples
FDA | Life Science History

FDA contracted with global partners to analyze coronavirus samples

On Sept. 15, 2020, the FDA awarded a $5.4 million research contract to the University of Liverpool and…

Read More FDA contracted with global partners to analyze coronavirus samplesContinue

FDA published comparative performance data for COVID-19 molecular diagnostic tests
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Life Science History | Medical Device

FDA published comparative performance data for COVID-19 molecular diagnostic tests

On Sept. 15, 2020, the FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The…

Read More FDA published comparative performance data for COVID-19 molecular diagnostic testsContinue

Vaxart announced FDA clearance of IND application for oral COVID-19 vaccine
COVID-19 | FDA | Life Science History

Vaxart announced FDA clearance of IND application for oral COVID-19 vaccine

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

Read More Vaxart announced FDA clearance of IND application for oral COVID-19 vaccineContinue

BioNTech and Pfizer proposed expansion of pivotal COVID-19 vaccine trial
COVID-19 | FDA | Life Science History

BioNTech and Pfizer proposed expansion of pivotal COVID-19 vaccine trial

On Sept. 12, 2020, Pfizer and BioNTech announced that they had submitted an amended protocol to the FDA…

Read More BioNTech and Pfizer proposed expansion of pivotal COVID-19 vaccine trialContinue

Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.
Biotechnology | Diagnostics | FDA

Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.

On Sept. 11, 2020, Todos Medical announced that the FDA has added the TODOS 2019-nCoV RT-qPCR Detection Kit…

Read More Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.Continue

Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 Individual IgM and IgG antibody tests
FDA | Life Science History

Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 Individual IgM and IgG antibody tests

On Sept. 10, 2020, Accelerate Diagnostics and BioCheck announced that the FDA had issued an Emergency Use Authorization…

Read More Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 Individual IgM and IgG antibody testsContinue

COVID-19 | FDA | HIV | Vaccine

Pfizer and BioNTech to potentially supply EU with 200 million doses of mRNA-based vaccine candidate against SARS-CoV-2

On Sept. 9, 2020, Pfizer and BioNTech announced that they had submitted an amended protocol to the FDA…

Read More Pfizer and BioNTech to potentially supply EU with 200 million doses of mRNA-based vaccine candidate against SARS-CoV-2Continue

FDA approved Trelegy Ellipta as first once-daily single inhaler triple therapy for treatment of both asthma and COPD in the U.S.
Biotechnology | FDA | Therapeutics

FDA approved Trelegy Ellipta as first once-daily single inhaler triple therapy for treatment of both asthma and COPD in the U.S.

On Sept. 10, 2020, GlaxoSmithKline and Innoviva announced the U.S. Food and Drug Administration (FDA) had approved a…

Read More FDA approved Trelegy Ellipta as first once-daily single inhaler triple therapy for treatment of both asthma and COPD in the U.S.Continue

INOVIO added Thermo Fisher Scientific to global manufacturing consortium
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

INOVIO added Thermo Fisher Scientific to global manufacturing consortium

On Sept. 8, 2020, INOVIO announced that Thermo Fisher Scientific, the world leader in serving science, had signed…

Read More INOVIO added Thermo Fisher Scientific to global manufacturing consortiumContinue

OraSure’s ORAcollect-RNA device Included in EUA granted to MiraDx for SARS-CoV-2 test
Biotechnology | COVID-19 | FDA

OraSure’s ORAcollect-RNA device Included in EUA granted to MiraDx for SARS-CoV-2 test

On Sept. 3, 2020, OraSure Technologies announced that its ORAcollect-ᄋRNA (OR-100) collection device was included along with other…

Read More OraSure’s ORAcollect-RNA device Included in EUA granted to MiraDx for SARS-CoV-2 testContinue

Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systems
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Influenza

Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systems

On Sept. 3, 2020, Roche announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the…

Read More Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systemsContinue

City of Hope doctors lead novel clinical trial to treat cancer patients with COVID-19
COVID-19 | Disease | FDA | Therapeutics

City of Hope doctors lead novel clinical trial to treat cancer patients with COVID-19

On Sept. 1, 2020, City of Hope announced that it was investigating an innovative treatment for cancer patients…

Read More City of Hope doctors lead novel clinical trial to treat cancer patients with COVID-19Continue

Roche received FDA approval for first HIV-1/HIV-2 Qualitative test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
FDA | HIV | Life Science History

Roche received FDA approval for first HIV-1/HIV-2 Qualitative test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

On Sept. 1, 2020, Roche announced FDA approval for the cobasᆴ HIV-1/HIV-2 Qualitative Test for use on the…

Read More Roche received FDA approval for first HIV-1/HIV-2 Qualitative test on the cobas 6800/8800 Systems in the fight against HIV/AIDSContinue

T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic test
COVID-19 | FDA | Life Science History

T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic test

On Aug. 31, 2020, T2 Biosystems announced that the FDA had issued an Emergency Use Authorization (EUA) for…

Read More T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic testContinue

FDA expanded Emergency Use Authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19
COVID-19 | FDA | Life Science History

FDA expanded Emergency Use Authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19

On Aug. 28, 2020, the FDA issued an emergency use authorization (EUA) to Yale School of Public Health…

Read More FDA expanded Emergency Use Authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19Continue

Gileadメs investigational antiviral Vekluryᆴ (remdesivir) received FDA Emergency Use Authorization for treatment of patients with moderate COVID-19
COVID-19 | FDA | Life Science History

Gileadメs investigational antiviral Vekluryᆴ (remdesivir) received FDA Emergency Use Authorization for treatment of patients with moderate COVID-19

On Aug. 28, 2020, Gilead Sciences announced the FDA expanded the Emergency Use Authorization (EUA) enabling use of…

Read More Gileadメs investigational antiviral Vekluryᆴ (remdesivir) received FDA Emergency Use Authorization for treatment of patients with moderate COVID-19Continue

Laurent Pharmaceuticals received FDA approval to initiate its COVID-19 phase 2 clinical trial in the U.S.
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Laurent Pharmaceuticals received FDA approval to initiate its COVID-19 phase 2 clinical trial in the U.S.

On Aug. 27, 2020, Laurent Pharmaceuticals announced that it had received approval from the U.S. Food and Drug…

Read More Laurent Pharmaceuticals received FDA approval to initiate its COVID-19 phase 2 clinical trial in the U.S.Continue

Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test for healthcare professionals received FDA Emergency Use Authorization
COVID-19 | FDA | Life Science History

Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test for healthcare professionals received FDA Emergency Use Authorization

On Aug. 26, 2020, Abbott announced the FDA had issued Emergency Use Authorization (EUA) for its BinaxNOWル COVID-19…

Read More Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test for healthcare professionals received FDA Emergency Use AuthorizationContinue

XBiotech announced COVID-19 candidate therapy
Biotechnology | COVID-19 | FDA | Therapeutics

XBiotech announced COVID-19 candidate therapy

On Aug. 24, 2020, XBiotech announced that the U.S. Food and Drug Administration (FDA) issued an emergency use…

Read More XBiotech announced COVID-19 candidate therapyContinue

FDA issued Emergency Use Authorization for convalescent plasma as potential promising COVIDヨ19 treatment
COVID-19 | FDA | Life Science History

FDA issued Emergency Use Authorization for convalescent plasma as potential promising COVIDヨ19 treatment

On Aug. 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the…

Read More FDA issued Emergency Use Authorization for convalescent plasma as potential promising COVIDヨ19 treatmentContinue

Mayo Clinic discontinued enrollment in Expanded Access Program for convalescent plasma with FDA Emergency Use Authorization
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Mayo Clinic discontinued enrollment in Expanded Access Program for convalescent plasma with FDA Emergency Use Authorization

On Aug. 23, 2020, the Mayo Clinic announced that with the FDA Emergency Use Authorization of convalescent plasma,…

Read More Mayo Clinic discontinued enrollment in Expanded Access Program for convalescent plasma with FDA Emergency Use AuthorizationContinue

Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 antibody testing system
COVID-19 | FDA | Life Science History

Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 antibody testing system

On Aug. 19, 2020, Accelerate Diagnostics and BioCheck announced that the FDA had issued an Emergency Use Authorization…

Read More Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 antibody testing systemContinue

FDA approved teatment for rare disease affecting optic nerves, spinal cord
Biotechnology | FDA | Neurology

FDA approved teatment for rare disease affecting optic nerves, spinal cord

On Aug. 17, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Enspryng (satralizumab-mwge) for the treatment…

Read More FDA approved teatment for rare disease affecting optic nerves, spinal cordContinue

FDA issued Emergency Use Authorization to Yale School of Public Health for SalivaDirect method of saliva sample processing
COVID-19 | FDA | Life Science History

FDA issued Emergency Use Authorization to Yale School of Public Health for SalivaDirect method of saliva sample processing

On Aug. 15, 2020, the FDA issued an emergency use authorization (EUA) to Yale School of Public Health…

Read More FDA issued Emergency Use Authorization to Yale School of Public Health for SalivaDirect method of saliva sample processingContinue

Quick and affordable saliva-based COVID-19 test developed by Yale scientists received FDA Emergency Use Authorization
FDA | Life Science History

Quick and affordable saliva-based COVID-19 test developed by Yale scientists received FDA Emergency Use Authorization

On Aug. 15, 2020, a saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public…

Read More Quick and affordable saliva-based COVID-19 test developed by Yale scientists received FDA Emergency Use AuthorizationContinue

Baxter obtained FDA Emergency Use Authorizations for HF20 set and ST set used in CRRT during Covid-19 pandemic
COVID-19 | FDA | Life Science History

Baxter obtained FDA Emergency Use Authorizations for HF20 set and ST set used in CRRT during Covid-19 pandemic

On Aug. 12, 2020, Baxter announced it had received Emergency Use Authorizations (EUAs) from the FDA for the…

Read More Baxter obtained FDA Emergency Use Authorizations for HF20 set and ST set used in CRRT during Covid-19 pandemicContinue

FDA approved targeted treatment for rare Duchenne Muscular Dystrophy mutation
FDA | Life Science History

FDA approved targeted treatment for rare Duchenne Muscular Dystrophy mutation

On Aug. 12, 2020, the FDA granted accelerated approval to NS Pharma’s Viltepso (viltolarsen) injection for the treatment…

Read More FDA approved targeted treatment for rare Duchenne Muscular Dystrophy mutationContinue

Hologic launched validated pooling protocol for COVID-19 testing
COVID-19 | FDA | Life Science History

Hologic launched validated pooling protocol for COVID-19 testing

On Aug. 11, 2020, Hologic announced that it has validated use of its Aptimaᆴ and Panther Fusionᆴ molecular…

Read More Hologic launched validated pooling protocol for COVID-19 testingContinue

Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19
COVID-19 | FDA | Therapeutics

Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19

On Aug. 10, 2020, Gilead Sciences announced that it had submitted a New Drug Application (NDA) to the…

Read More Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19Continue

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