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Home / FDA - Page 9

FDA

U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults

On Oct. 19, 2022, the U.S. Food and Drug Administration (FDA) recommended the use of the Novavax COVID-19…

Read More U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adultsContinue

Moderna received Authorization for Emergency Use from FDA of Omicron-targeting bivalent COVID-19 booster vaccine for children
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna received Authorization for Emergency Use from FDA of Omicron-targeting bivalent COVID-19 booster vaccine for children

On Oct. 12, 2022, Moderna announced that it had received emergency use authorization from the U.S. Food and…

Read More Moderna received Authorization for Emergency Use from FDA of Omicron-targeting bivalent COVID-19 booster vaccine for childrenContinue

Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children
Biotechnology | CDC | COVID-19 | FDA

Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children

On Oct. 12, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use…

Read More Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in childrenContinue

FDA Authorized PCR-Based Mpox Test
Biotechnology | Diagnostics | FDA | Infectious Disease

FDA Authorized PCR-Based Mpox Test

On Oct. 7, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to…

Read More FDA Authorized PCR-Based Mpox TestContinue

Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age
Biotechnology | COVID-19 | FDA

Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age

On Sept. 28, 2022, Pfizer and BioNTech announced they have completed a submission to the U.S. Food and…

Read More Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of ageContinue

FDA Approved Daxxify, a New Anti-Wrinkle Drug
Biotechnology | FDA | Therapeutics

FDA Approved Daxxify, a New Anti-Wrinkle Drug

On Sept. 7, 2022, the U.S. Food and Drug Administration (FDA) announced it had approved Revance Therapeutics’ DAXXIFY…

Read More FDA Approved Daxxify, a New Anti-Wrinkle DrugContinue

Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

On Aug. 22, 2022, Pfizer and BioNTech announced they had completed a submission to the U.S. Food and…

Read More Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccineContinue

Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccine
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccine

On Aug. 22, 2022, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of Moderna…

Read More Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccineContinue

U.S. Department of Health and Human Services made more vaccine doses available to support Mpox response
FDA | Life Science History

U.S. Department of Health and Human Services made more vaccine doses available to support Mpox response

On Aug. 15, 2022, the U.S. Department of Health and Human Services announced that was making up to…

Read More U.S. Department of Health and Human Services made more vaccine doses available to support Mpox responseContinue

Pfizer announced submission of New Drug Application to the U.S. FDA for PAXLOVID
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Pfizer announced submission of New Drug Application to the U.S. FDA for PAXLOVID

On Jun. 30 2022, Pfizer announced the submission of a New Drug Application (NDA) to the U.S. Food…

Read More Pfizer announced submission of New Drug Application to the U.S. FDA for PAXLOVIDContinue

Pfizer and BioNTech announced agreement with U.S. Government to provide additional doses of COVID-19 Vaccine
COVID-19 | FDA | Life Science History

Pfizer and BioNTech announced agreement with U.S. Government to provide additional doses of COVID-19 Vaccine

On Jun. 30, 2022, Pfizer and BioNTech announced a vaccine supply agreement with the U.S. government to support…

Read More Pfizer and BioNTech announced agreement with U.S. Government to provide additional doses of COVID-19 VaccineContinue

COVID-19 Wheel of Fortune
Biotechnology | Cartoons - Original | COVID-19 | Diagnostics | Disease | FDA | Life Science History | Medicine | Non-Profit Research | Pharmaceutical | Therapeutics | U.S. Congress | Vaccine

COVID-19 Wheel of Fortune

Play the COVID-19 Wheel of Fortune and see how lucky you are! You have two wheels to choose…

Read More COVID-19 Wheel of FortuneContinue

Emergent BioSolutions announced FDA acceptance of Biologics License Application for AV7909 Anthrax vaccine candidate
FDA | Life Science History

Emergent BioSolutions announced FDA acceptance of Biologics License Application for AV7909 Anthrax vaccine candidate

On Jun. 24, 2022, Emergent BioSolutions announced that the U.S. Food and Drug Administration accepted for review the…

Read More Emergent BioSolutions announced FDA acceptance of Biologics License Application for AV7909 Anthrax vaccine candidateContinue

U.S. FDA approved Merck’s VAXNEUVANCE for prevention of invasive pneumococcal disease in infants and children
Biotechnology | FDA | Infectious Disease | Vaccine

U.S. FDA approved Merck’s VAXNEUVANCE for prevention of invasive pneumococcal disease in infants and children

On Jun. 22, 2022, Merck announced that that the U.S. Food and Drug Administration (FDA) had approved an…

Read More U.S. FDA approved Merck’s VAXNEUVANCE for prevention of invasive pneumococcal disease in infants and childrenContinue

Pfizer-BioNTech COVID-19 vaccine received FDA Emergency Use Authorization for children 6 months through 4 years of age
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Pfizer-BioNTech COVID-19 vaccine received FDA Emergency Use Authorization for children 6 months through 4 years of age

On Jun. 17, 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration (FDA) had granted emergency…

Read More Pfizer-BioNTech COVID-19 vaccine received FDA Emergency Use Authorization for children 6 months through 4 years of ageContinue

Veru submitted EUA to U.S. FDA for Sabizabulin, its anti-Inflammatory drug candidate for hospitalized COVID-19 patients
COVID-19 | FDA | Therapeutics

Veru submitted EUA to U.S. FDA for Sabizabulin, its anti-Inflammatory drug candidate for hospitalized COVID-19 patients

On Jun. 7, 2022, Veru announced that is had submitted an emergency use authorization (EUA) application to the…

Read More Veru submitted EUA to U.S. FDA for Sabizabulin, its anti-Inflammatory drug candidate for hospitalized COVID-19 patientsContinue

Moderna filed for authorization of Its COVID-19 vaccine in young children six months to under six years of age
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna filed for authorization of Its COVID-19 vaccine in young children six months to under six years of age

On Apr. 28, 2022, Moderna announced that it had submitted a request for emergency use authorization (EUA) for…

Read More Moderna filed for authorization of Its COVID-19 vaccine in young children six months to under six years of ageContinue

Pfizer and BioNTech submitted application for U.S. EUA for COVID-19 vaccine booster dose in children 5 through 11 years of age
Biotechnology | COVID-19 | FDA | Vaccine

Pfizer and BioNTech submitted application for U.S. EUA for COVID-19 vaccine booster dose in children 5 through 11 years of age

On Apr. 26, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA)…

Read More Pfizer and BioNTech submitted application for U.S. EUA for COVID-19 vaccine booster dose in children 5 through 11 years of ageContinue

Veklury (Remdesivir) was first and only approved treatment for pediatric patients under 12 years of age with COVID-19
Biotechnology | COVID-19 | FDA | Infectious Disease

Veklury (Remdesivir) was first and only approved treatment for pediatric patients under 12 years of age with COVID-19

On Apr. 25, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental…

Read More Veklury (Remdesivir) was first and only approved treatment for pediatric patients under 12 years of age with COVID-19Continue

Regeneron antibody cocktail approved by European Commission to treat and prevent COVID-19
COVID-19 | FDA | Life Science History

Regeneron antibody cocktail approved by European Commission to treat and prevent COVID-19

On Nov. 12, 2021, Regeneron announced that the U.S. Food and Drug Administration had extended by three months…

Read More Regeneron antibody cocktail approved by European Commission to treat and prevent COVID-19Continue

Novavax and Serum Institute of India received EUA for COVID-19 vaccine in Thailand
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Novavax and Serum Institute of India received EUA for COVID-19 vaccine in Thailand

On Apr. 8, 2022, Novavax announced and Serum Institute of India (SII), the world’s largest vaccine manufacturer by…

Read More Novavax and Serum Institute of India received EUA for COVID-19 vaccine in ThailandContinue

Sorrento reported FDA clearance for phase 2/3 study for Abivertinib in treatment of pospitalized patients with severe pneumonia due to COVID-19
Biotechnology | COVID-19 | FDA | Life Science History | Therapeutics

Sorrento reported FDA clearance for phase 2/3 study for Abivertinib in treatment of pospitalized patients with severe pneumonia due to COVID-19

On Mar. 31, 2022, Sorrento Therapeutics announced that the FDA had given clearance to commence the Phase 3…

Read More Sorrento reported FDA clearance for phase 2/3 study for Abivertinib in treatment of pospitalized patients with severe pneumonia due to COVID-19Continue

Moderna received FDA approval for EUA of 2nd booster dose of its COVID-19 vaccine, mRNA-1273
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna received FDA approval for EUA of 2nd booster dose of its COVID-19 vaccine, mRNA-1273

On Mar. 29, 2022, Moderna announced that it had received approval from the U.S. Food and Drug Administration…

Read More Moderna received FDA approval for EUA of 2nd booster dose of its COVID-19 vaccine, mRNA-1273Continue

Pfizer and BioNTech received expanded U.S. EUA for additional COVID-19 vaccine booster in individuals Aged 50 Years and older
Biotechnology | COVID-19 | FDA | Pharmaceutical | Therapeutics | Vaccine

Pfizer and BioNTech received expanded U.S. EUA for additional COVID-19 vaccine booster in individuals Aged 50 Years and older

On Mar. 29, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…

Read More Pfizer and BioNTech received expanded U.S. EUA for additional COVID-19 vaccine booster in individuals Aged 50 Years and olderContinue

US Food and Drug Administration revised EUA for sotrovimab due to Omicron BA.2 subvariant
Biotechnology | FDA | Life Science History

US Food and Drug Administration revised EUA for sotrovimab due to Omicron BA.2 subvariant

On Mar. 25, 2022, GlaxoSmithKline and Vir Biotechnology announced that the US Food and Drug Administration had amended…

Read More US Food and Drug Administration revised EUA for sotrovimab due to Omicron BA.2 subvariantContinue

Moderna submited amendment to EUA for an additional booster dose of its COVID-19 vaccine in the U.S.
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna submited amendment to EUA for an additional booster dose of its COVID-19 vaccine in the U.S.

On Mar. 17, 2022, Moderna announced that it had submitted a request to the U.S. Food and Drug…

Read More Moderna submited amendment to EUA for an additional booster dose of its COVID-19 vaccine in the U.S.Continue

FDA made low-risk determination for marketing of products from genome-edited beef cattle after safety review
FDA | Genomics | Life Science History

FDA made low-risk determination for marketing of products from genome-edited beef cattle after safety review

On Mar. 7, 2022, the U.S. Food and Drug Administration announced it had made a low-risk determination for…

Read More FDA made low-risk determination for marketing of products from genome-edited beef cattle after safety reviewContinue

Sorrento announced FDA authorization to proceed with phase 1 study of Intranasal STI-9199 against Covid-19 viruses
Biotechnology | COVID-19 | FDA | Therapeutics

Sorrento announced FDA authorization to proceed with phase 1 study of Intranasal STI-9199 against Covid-19 viruses

On Mar. 2, 2022, Sorrento Therapeutics announced that it had received clearance from the FDA for its investigational…

Read More Sorrento announced FDA authorization to proceed with phase 1 study of Intranasal STI-9199 against Covid-19 virusesContinue

Pfizer and BioNTech updated rolling submission for EUA of COVID-19 caccine in children 6 months through 4 years of Age
COVID-19 | FDA | Life Science History

Pfizer and BioNTech updated rolling submission for EUA of COVID-19 caccine in children 6 months through 4 years of Age

On Feb. 11, 2022, Pfizer and BioNTech announced plans to extend their rolling submission to the U.S. Food…

Read More Pfizer and BioNTech updated rolling submission for EUA of COVID-19 caccine in children 6 months through 4 years of AgeContinue

Pfizer and BioNTech initiated rolling submission for EUA of COVID-19 vaccine in children 6 months through 4 years of age
COVID-19 | FDA | Life Science History

Pfizer and BioNTech initiated rolling submission for EUA of COVID-19 vaccine in children 6 months through 4 years of age

On Feb. 1, 2022, Pfizer and BioNTech announced that following a request from the U.S. Food and Drug…

Read More Pfizer and BioNTech initiated rolling submission for EUA of COVID-19 vaccine in children 6 months through 4 years of ageContinue

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