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Home / FDA - Page 7

FDA

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

Vekluryᆴ (Remdesivir) was first and only approved treatment for pediatric patients under 12 years of age with COVID-19
COVID-19 | FDA | Life Science History

Vekluryᆴ (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) had approved a…

Read More Vekluryᆴ (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

Moderna received full U.S. FDA approval for COVID-19 vaccine Spikevax
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna received full U.S. FDA approval for COVID-19 vaccine Spikevax

On Jan. 31, 2022, Moderna announced the U.S. Food and Drug Administration (FDA)  had approved the Biologics License…

Read More Moderna received full U.S. FDA approval for COVID-19 vaccine SpikevaxContinue

Novavax submitted request to U.S. FDA for Emergency Use Authorization of COVID-19 vaccine
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Novavax submitted request to U.S. FDA for Emergency Use Authorization of COVID-19 vaccine

On Jan. 31, 2022, Novavax announced that it had submitted a request to the U.S Food and Drug…

Read More Novavax submitted request to U.S. FDA for Emergency Use Authorization of COVID-19 vaccineContinue

InteliSwabᆴ COVID-19 rapid tests receive U.S. FDA authorization for pediatric use
COVID-19 | FDA | Life Science History

InteliSwabᆴ COVID-19 rapid tests receive U.S. FDA authorization for pediatric use

On Jan. 31, 2022, OraSure Technologies announced that its InteliSwabᆴ COVID-19 rapid tests had been authorized by the…

Read More InteliSwabᆴ COVID-19 rapid tests receive U.S. FDA authorization for pediatric useContinue

Veru announced FDA Grant of Fast Track Designation for Sabizabulin for treatment of hospitalized COVID-19 patients
COVID-19 | FDA | Life Science History

Veru announced FDA Grant of Fast Track Designation for Sabizabulin for treatment of hospitalized COVID-19 patients

On Jan. 31, 2022, Veru announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…

Read More Veru announced FDA Grant of Fast Track Designation for Sabizabulin for treatment of hospitalized COVID-19 patientsContinue

Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenic
COVID-19 | FDA | Life Science History | NIH

Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenic

On Jan. 26, 2022, the NIH announced that adults who had previously received a full regimen of any…

Read More Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenicContinue

FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression
COVID-19 | FDA | Life Science History

FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression

On Jan. 20, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration had granted expedited approval…

Read More FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progressionContinue

South Korea Ministry of Food and Drug Safety approved Novavax COVID-19 vaccine
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

South Korea Ministry of Food and Drug Safety approved Novavax COVID-19 vaccine

On Jan. 12, 2022, Novavax and SK bioscience, a vaccine business subsidiary of Korea-based SK Group, announced that…

Read More South Korea Ministry of Food and Drug Safety approved Novavax COVID-19 vaccineContinue

BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants
COVID-19 | FDA | Life Science History

BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants

On Jan. 11, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…

Read More BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variantsContinue

Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19
COVID-19 | FDA | Life Science History

Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19

On Jan. 10, 2022, Novartis Molecular Partners announced that Part A of the EMPATHY clinical trial that compared…

Read More Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19Continue

NRx Pharmac submited EUA Application to US FDA for ZYESAMIᆴ (aviptadil) to treat patients at risk of death from COVID-19
COVID-19 | FDA | Life Science History | NIH

NRx Pharmac submited EUA Application to US FDA for ZYESAMIᆴ (aviptadil) to treat patients at risk of death from COVID-19

On Jan 5, 2022, NRx Pharmaceuticals announced that it had submitted an application for Emergency Use Authorization (EUA)…

Read More NRx Pharmac submited EUA Application to US FDA for ZYESAMIᆴ (aviptadil) to treat patients at risk of death from COVID-19Continue

Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older
COVID-19 | FDA | Life Science History

Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older

On Jan. 3, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…

Read More Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and olderContinue

FDA authorized COVID-19 Over-the-Counter test based on data from NIH Independent Test Assessment Program
COVID-19 | FDA | Life Science History

FDA authorized COVID-19 Over-the-Counter test based on data from NIH Independent Test Assessment Program

On Dec. 27, 2021, the U.S. Food and Drug Administration authorized an over-the-counter (OTC) COVID-19 antigen test, the…

Read More FDA authorized COVID-19 Over-the-Counter test based on data from NIH Independent Test Assessment ProgramContinue

COVID-19 heroes & Remembrance
Biotechnology | Cartoons - Original | COVID-19 | Diagnostics | FDA | Life Science History | Non-Profit Research | Pharmaceutical | Therapeutics | U.S. Congress | Vaccine

COVID-19 heroes & Remembrance

Our Heroes and Remembrance illustration has Maurice Ralph Hilleman and John Enders, pioneering developers of common vaccines, and…

Read More COVID-19 heroes & RemembranceContinue

Merck and Ridgeback’s molnupiravir received U.S. FDA EUA for treatment of high-risk adults with COVID-19
Biotechnology | COVID-19 | FDA | Medicine | Pharmaceutical | Therapeutics

Merck and Ridgeback’s molnupiravir received U.S. FDA EUA for treatment of high-risk adults with COVID-19

On Dec. 23, 2021, Merck and Ridgeback Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) had…

Read More Merck and Ridgeback’s molnupiravir received U.S. FDA EUA for treatment of high-risk adults with COVID-19Continue

Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment

On Dec. 22, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…

Read More Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatmentContinue

CytoDyn submited protocol with FDA for phase 3 Registrational trial of leronlimab for critically ill COVID-19 population
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

CytoDyn submited protocol with FDA for phase 3 Registrational trial of leronlimab for critically ill COVID-19 population

On Dec. 9, 2021, CytoDyn announced that it had submitted a Phase 3, randomized, double blind, placebo controlled…

Read More CytoDyn submited protocol with FDA for phase 3 Registrational trial of leronlimab for critically ill COVID-19 populationContinue

Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 16 years and older
COVID-19 | FDA | Life Science History

Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 16 years and older

On Dec. 9, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…

Read More Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 16 years and olderContinue

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