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Home / FDA - Page 16

FDA

Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.
Biotechnology | COVID-19 | FDA | Vaccine

Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.

On Dec. 17, 2020, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…

Read More Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.Continue

Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test
COVID-19 | FDA | Life Science History

Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test

On Dec. 16, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for virtually guided…

Read More Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid testContinue

Meridian received NIH award for supporting rapid development of Revogeneᆴ molecular test for SARS-CoV-2
FDA | Life Science History | NIH

Meridian received NIH award for supporting rapid development of Revogeneᆴ molecular test for SARS-CoV-2

On Dec. 16, 2020, Meridian Bioscience announced that it had been awarded funding in the amount of approximately…

Read More Meridian received NIH award for supporting rapid development of Revogeneᆴ molecular test for SARS-CoV-2Continue

FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19
COVID-19 | FDA | Life Science History

FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19

On Dec. 15, 2020, the FDA granted emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home…

Read More FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19Continue

CIRM-funded project targeting sickle cell disease received green light for clinical trial
Biotechnology | CRISPR | FDA | Therapeutics

CIRM-funded project targeting sickle cell disease received green light for clinical trial

On Dec.14, 2020, the US Food and Drug Administration (FDA) announced they had granted Investigational New Drug (IND)…

Read More CIRM-funded project targeting sickle cell disease received green light for clinical trialContinue

FDA approved first intentional genomic alteration in domestic pigs for both human food, potential therapeutic uses
FDA | Life Science History

FDA approved first intentional genomic alteration in domestic pigs for both human food, potential therapeutic uses

On Dec. 14, 2020, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in…

Read More FDA approved first intentional genomic alteration in domestic pigs for both human food, potential therapeutic usesContinue

FDA approved first-of-its-kind Intentional genomic alteration in Line of domestic pigs for human food, potential therapeutic uses
FDA | Life Science History

FDA approved first-of-its-kind Intentional genomic alteration in Line of domestic pigs for human food, potential therapeutic uses

On Dec. 14, 2020, the U.S. Food and Drug Administration (FDA) approved the a first-of-its-kind intentional genomic alteration…

Read More FDA approved first-of-its-kind Intentional genomic alteration in Line of domestic pigs for human food, potential therapeutic usesContinue

US FDA issued Emergency Use Authorization for first COVID-19 vaccine
COVID-19 | FDA | Life Science History

US FDA issued Emergency Use Authorization for first COVID-19 vaccine

On Dec. 11, 2020, the FDA issued the first emergency use authorization (EUA) for a vaccine for the…

Read More US FDA issued Emergency Use Authorization for first COVID-19 vaccineContinue

Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJM
COVID-19 | FDA | Therapeutics

Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJM

On Dec. 11, 2020, Eli Lilly and Incyte announced The New England Journal of Medicine had published the…

Read More Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJMContinue

US Dept of Veterans Affairs announced initial plans for COVID-19 vaccine distribution
COVID-19 | FDA | Life Science History

US Dept of Veterans Affairs announced initial plans for COVID-19 vaccine distribution

On Dec. 10, 2020, the U.S. Dept. of Veterans Affairs (VA) announced a preliminary plan for distributing COVID-19…

Read More US Dept of Veterans Affairs announced initial plans for COVID-19 vaccine distributionContinue

Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
Biotechnology | FDA | Infectious Disease | Vaccine

Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials

On Dec. 10, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…

Read More Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trialsContinue

Pfizer and BioNTech received FDA Advisory Committee vote supporting EUA for COVID-19 vaccine in the US
COVID-19 | FDA | Life Science History

Pfizer and BioNTech received FDA Advisory Committee vote supporting EUA for COVID-19 vaccine in the US

On Dec. 10, 2020, Pfizer and BioNTech announced that the FDA Vaccines and Related Biological Products Advisory Committee…

Read More Pfizer and BioNTech received FDA Advisory Committee vote supporting EUA for COVID-19 vaccine in the USContinue

Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
Biotechnology | FDA | Infectious Disease | Vaccine

Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials

On Dec. 9, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…

Read More Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trialsContinue

LabCorp received FDA Authorization to make at-home COVID-19 collection kits available rhrough retail
COVID-19 | FDA | Life Science History

LabCorp received FDA Authorization to make at-home COVID-19 collection kits available rhrough retail

On Dec. 9, 2020, LabCorp announced that the FDA had granted Emergency Use Authorization (EUA) for the Pixel…

Read More LabCorp received FDA Authorization to make at-home COVID-19 collection kits available rhrough retailContinue

FDA accepted for priority review the BLA for Pfizerメs investigational 20-valent pneumococcal conjugate vaccine
FDA | Life Science History

FDA accepted for priority review the BLA for Pfizerメs investigational 20-valent pneumococcal conjugate vaccine

On Dec. 8, 2020, Pfizer announced that the FDA accepted for priority review a Biologics License Application (BLA)…

Read More FDA accepted for priority review the BLA for Pfizerメs investigational 20-valent pneumococcal conjugate vaccineContinue

Chimerix announced FDA acceptance of NDA for brincidofovir as a medical countermeasure for smallpox
FDA | Life Science History

Chimerix announced FDA acceptance of NDA for brincidofovir as a medical countermeasure for smallpox

On Dec. 7, 2020, Chimerix announced that the FDA has accepted the filing of a New Drug Application…

Read More Chimerix announced FDA acceptance of NDA for brincidofovir as a medical countermeasure for smallpoxContinue

FDA approved Saxenda for the treatment of obesity in adolescents aged 12-17
FDA | Medicine

FDA approved Saxenda for the treatment of obesity in adolescents aged 12-17

On Dec. 4, 2020, Novo Nordisk announced that the FDA approved an updated label for Saxenda (liraglutide) injection…

Read More FDA approved Saxenda for the treatment of obesity in adolescents aged 12-17Continue

Roche received FDA Emergency Use Authorization for new test to measure level of SARS-CoV-2 antibodies
FDA | Life Science History

Roche received FDA Emergency Use Authorization for new test to measure level of SARS-CoV-2 antibodies

On Dec. 2, 2020, Roche announced that its Elecsysᆴ Anti-SARS-CoV-2 S antibody test had received Emergency Use Authorization…

Read More Roche received FDA Emergency Use Authorization for new test to measure level of SARS-CoV-2 antibodiesContinue

FDA approved first PSMA-targeted PET imaging drug for men with prostate cancer
FDA | Life Science History

FDA approved first PSMA-targeted PET imaging drug for men with prostate cancer

On Dec. 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) ヨ the first drug for…

Read More FDA approved first PSMA-targeted PET imaging drug for men with prostate cancerContinue

VBI Vaccines announced submission of BLA to FDA for 3-antigen prophylactic Hepatitis B vaccine
FDA | Life Science History

VBI Vaccines announced submission of BLA to FDA for 3-antigen prophylactic Hepatitis B vaccine

On Dec. 1, 2020, VBI Vaccines announced the submission of a Biologics License Application (BLA) to the FDA…

Read More VBI Vaccines announced submission of BLA to FDA for 3-antigen prophylactic Hepatitis B vaccineContinue

Moderna announced primary efficacy analysis in phase 3 COVE study for COVID-19 vaccine candidate
Biotechnology | Clinical Research | COVID-19 | Diagnostics | FDA | Infectious Disease | Vaccine

Moderna announced primary efficacy analysis in phase 3 COVE study for COVID-19 vaccine candidate

On Nov. 30, 2020, Moderna announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273…

Read More Moderna announced primary efficacy analysis in phase 3 COVE study for COVID-19 vaccine candidateContinue

Altimmune announced submission of Investigational NDA for AdCOVIDル a single-dose intranasal COVID-19 vaccine
COVID-19 | FDA | Life Science History

Altimmune announced submission of Investigational NDA for AdCOVIDル a single-dose intranasal COVID-19 vaccine

On Nov. 25, 2020, Altimmune announced that it had submitted an Investigational New Drug (IND) application to the…

Read More Altimmune announced submission of Investigational NDA for AdCOVIDル a single-dose intranasal COVID-19 vaccineContinue

Commonly used antibiotic showed promise for combating Zika infections
FDA | Life Science History | NIH

Commonly used antibiotic showed promise for combating Zika infections

On Nov. 24, 2020, preclinical study by the National Institutes of Health (NIH) suggested FDA-approved tetracycline-based antibiotics may…

Read More Commonly used antibiotic showed promise for combating Zika infectionsContinue

Bellerophon announced results of interim analysis of phase 3 COViNOX study of INOpulseᆴ for COVID-19
COVID-19 | FDA | Life Science History

Bellerophon announced results of interim analysis of phase 3 COViNOX study of INOpulseᆴ for COVID-19

On Nov. 23, 2020, Bellerophon Therapeutics announced that the independent Data Monitoring Committee (DMC) had completed its pre-specified…

Read More Bellerophon announced results of interim analysis of phase 3 COViNOX study of INOpulseᆴ for COVID-19Continue

FDA expanded approval of influenza treatment to post-exposure prevention
Biotechnology | FDA | Infectious Disease | Influenza | Therapeutics

FDA expanded approval of influenza treatment to post-exposure prevention

On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) expanded the approved indication for Genentech’s Xofluza…

Read More FDA expanded approval of influenza treatment to post-exposure preventionContinue

Merck submited applications for licensure of V114, 15-valent pneumococcal conjugate vaccine, for use in adults
FDA | Life Science History

Merck submited applications for licensure of V114, 15-valent pneumococcal conjugate vaccine, for use in adults

On Nov. 23, 2020, Merck, known as MSD outside the U.S. and Canada, announced the company had submitted…

Read More Merck submited applications for licensure of V114, 15-valent pneumococcal conjugate vaccine, for use in adultsContinue

Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR
FDA | HIV | Life Science History

Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR

On Nov. 23, 2020, Viatris announced tentative approval from the FDA for a New Drug Application for pediatric…

Read More Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFARContinue

FDA approved first drug to treat rare metabolic disorder
Disease | FDA | Rare Disease

FDA approved first drug to treat rare metabolic disorder

On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’s Oxlumo (lumasiran) as the…

Read More FDA approved first drug to treat rare metabolic disorderContinue

FDA authorized monoclonal antibodies for treatment of COVID-19
COVID-19 | FDA | Life Science History

FDA authorized monoclonal antibodies for treatment of COVID-19

On Nov. 21, 2020, the FDA issued an emergency use authorization (EUA) for Regeneron Pharmaceuticals’ casirivimab and imdevimab…

Read More FDA authorized monoclonal antibodies for treatment of COVID-19Continue

Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization
COVID-19 | FDA | Life Science History

Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization

On Nov. 21, 2020, Regeneron announced that the antibody cocktail casirivimab and imdevimab administered together (also known as…

Read More Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use AuthorizationContinue

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