GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older

13 June 2025 - Regulatory decision anticipated H1, 2026. ...

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Moderna receives US FDA approval for RSV vaccine, mRESVIA, in adults aged 18–59 at increased risk for RSV disease

12 June 2025 - Expanded indication builds on existing US FDA approval of mRESVIA for adults aged 60 and older. ...

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Oxford vaccine against deadly Nipah virus granted EMA PRIME designation

11 June 2025 - The University of Oxford’s vaccine to protect people from deadly Nipah virus has been granted support from ...

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Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE

31 May 2025 - mNEXSPIKE becomes Moderna's third FDA approved product. ...

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Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season

28 May 2025 -  2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...

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Moderna files FDA application for the LP.8.1 targeting COVID-19 vaccine

23 May 2025 - Moderna today announced that it has submitted an application to the US FDA for review of its ...

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Moderna provides update on BLA submission for combination vaccine against influenza and COVID-19

21 May 2025 -  Moderna today announced that in consultation with the US FDA, the Company has voluntarily withdrawn the ...

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US FDA approves BLA for Novavax's COVID-19 vaccine

19 May 2025 - Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the US. ...

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EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

7 May 2025 - The vaccine must not be used in people 65 years and above while review is underway. ...

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Latest update on US FDA BLA for Novavax's COVID-19 vaccine

23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, ...

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Arcturus Therapeutics receives US FDA fast track designation for the STARR mRNA vaccine candidate ARCT-2304 for pandemic influenza A virus H5N1

10 April 2025 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation for the self-amplifying mRNA ...

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Update on US FDA BLA for Novavax’s COVID-19 vaccine

2 April 2025 - Novavax can confirm that 1 April 2025, was the US FDA’s Prescription Drug User Fee Act date ...

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Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above

1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...

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European Commission approves Pfizer’s RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease

1 April 2025 - Abrysvo is the first and only RSV vaccine approved in the European Union for non-pregnant adults ...

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Bavarian Nordic receives US FDA approval of freeze dried smallpox and mpox vaccine

31 March 2025 - Bavarian Nordic today announced that the US FDA has approved the freeze dried formulation of Jynneos (smallpox ...

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