Pfizer and BioNTech submit for US emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 booster in children under 5 years

1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of ...

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Pfizer and BioNTech submit supplemental biologics license application for US FDA approval of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series or booster

24 February 2023 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the US ...

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Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection

22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...

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Icosavax granted FDA fast track designation for IVX-A12

21 February 2023 - Icosavax today announced the US FDA has granted fast track designation for IVX-A12, a bivalent respiratory syncytial ...

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US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

21 February 2023 - US FDA has set an action date for August 2023. ...

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FDA accepts Valneva’s chikungunya vaccine license application for priority review

20 February 2023 -  Valneva today announced that the US FDA has completed a filing review of its biologics license ...

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Moderna granted FDA breakthrough therapy designation for mRNA-1345, an investigational respiratory syncytial virus vaccine candidate

30 January 2023 - Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated ...

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Moderna considers price of $110-$130 for COVID-19 vaccine

9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...

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US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children

6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...

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Vaxcyte’s VAX-24 granted FDA breakthrough therapy designation for the prevention of invasive pneumococcal disease in adults

5 January 2023 - Breakthrough therapy designation for 24 valent investigational pneumococcal conjugate vaccine candidate based on positive topline proof of ...

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US FDA accepts for review the biologics license application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents

28 December 2022 - Pfizer today announced that the US FDA accepted for review a biologics license application for its investigational ...

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Valneva completes BLA submission to US FDA for its single shot chikungunya vaccine candidate

23 December 2022 - Valneva today announces that it has completed rolling submission of the biologics license application to the ...

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PharmaJet Partner Immunomic Therapeutics receives FDA fast track designation for pDNA vaccine for skin cancer

13 December 2022 - Vaccine exclusively delivered with the PharmaJet Stratis needle-free injection system. ...

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Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza

9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...

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FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age

8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...

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