Search articles in COVID-19

Found 98 articles

  • Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emer

    Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

    • 20 Jun 2022
    • Editor

    Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age).

  • Moderna Receives FDA Authorization for Emergency U

    Moderna Receives FDA Authorization for Emergency Use of its COVID-19 Vaccine for Children 6 Months of Age and Older

    • 20 Jun 2022
    • Editor

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg. The company has also received emergency use authorization for a 50 μg two-dose regimen of mRNA-1273.

  • Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally

    Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over

    • 14 Jun 2022
    • Editor

    Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over.

  • FDA Advisory Committee Recommends Emergency Use Au

    FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older

    • 8 Jun 2022
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention,

  • Evusheld significantly prevented COVID-19 disease

    Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase III treatment trial

    • 8 Jun 2022
    • Editor

    Detailed results from the TACKLE Phase III outpatient treatment trial showed AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442) provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo, with treatment with Evusheld earlier in the disease course leading to more favourable outcomes.1

  • Novavax Initiates Phase 3 Trial of its COVID-19 Om

    Novavax Initiates Phase 3 Trial of its COVID-19 Omicron Strain Vaccine as a Booster

    • 1 Jun 2022
    • Editor

    Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine.

  • Vaxzevria approved in the EU as third dose booster

    Vaxzevria approved in the EU as third dose booster against COVID-19

    • 24 May 2022
    • Editor

    AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.

  • AstraZeneca signs licence agreement with RQ Biotec

    AstraZeneca signs licence agreement with RQ Biotechnology for monoclonal antibodies against COVID-19

    • 18 May 2022
    • Editor

    AstraZeneca has entered into a licence agreement with RQ Biotechnology Ltd (RQ Bio) for a portfolio of early-stage monoclonal antibodies (mAbs) targeted against SARS-CoV-2, the virus that causes COVID-19.

  • Pfizer and BioNTech Granted U.S. Emergency Use Aut

    Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age

    • 18 May 2022
    • Editor

    Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.

  • FDA Approves Lilly and Incyte's OLUMIANT® (baricit

    FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19

    • 12 May 2022
    • Editor

    Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first.

  • Pfizer and BioNTech Submit Application for U.S. Em

    Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age

    • 27 Apr 2022
    • Editor

    Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

  • CureVac and GSK's Bivalent Second-Generation mRNA

    CureVac and GSK's Bivalent Second-Generation mRNA Vaccine Candidate Shown to be Highly Effective Against SARS-CoV-2 Variants in Preclinical Study

    • 21 Apr 2022
    • Editor

    CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced preclinical data demonstrating immune responses and protective efficacy of a bivalent second-generation COVID-19 vaccine candidate jointly developed with GSK, combining two mRNAs encoding for the Beta and the Delta variant.

  • Evusheld significantly protected against symptomat

    Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations

    • 21 Apr 2022
    • Editor

    Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo.

  • Initial Results from Novavax' COVID-19-Influenza V

    Initial Results from Novavax' COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine

    • 21 Apr 2022
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax' COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.

  • World Health Organization Updated Emergency Use Li

    World Health Organization Updated Emergency Use Listing Recommends Johnson & Johnson COVID-19 Vaccine for Booster Use

    • 4 Apr 2022
    • Editor

    The World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL) for the Johnson & Johnson COVID-19 vaccine, recommending the vaccine for use in boosted regimens in persons aged 18 years and older.

  • U.S. FDA grants priority review to Roche’s Actemra

    U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

    • 4 Apr 2022
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

  • Evotec expands screening capacity at Hamburg headq

    Evotec expands screening capacity at Hamburg headquarters through EFRE/REACT-EU-Grant

    • 31 Mar 2022
    • Editor

    Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that there will be two new high-throughput screening (“HTS”) facilities at the Company’s headquarters in Hamburg, as well as additional equipment for investigating the safety and efficacy of new therapeutic candidates.

  • Moderna Receives FDA Approval for Emergency Use Au

    Moderna Receives FDA Approval for Emergency Use Authorization of 2nd Booster Dose of its COVID-19 Vaccine, mRNA-1273

    • 30 Mar 2022
    • Editor

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level in adults...

  • Evusheld long-acting antibody combination approved

    Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

    • 28 Mar 2022
    • Editor

    AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

  • Evusheld long-acting antibody combination recommen

    Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

    • 25 Mar 2022
    • Editor

    AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.