Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2025
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. ...
Posted by Michael Wonder on 12 Jun 2025
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 ...
Posted by Michael Wonder on 29 May 2025
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 ...
Posted by Michael Wonder on 14 May 2025
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. ...
Posted by Michael Wonder on 02 Apr 2025
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 ...
Posted by Michael Wonder on 01 Apr 2025
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 ...
Posted by Michael Wonder on 27 Mar 2025
European Commission approves Merck’s Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
26 March 2025 - EC decision marks the fourth approval for Capvaxive for pneumococcal vaccination in adults ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted by Michael Wonder on 15 Feb 2025
European Commission approves CSL and Arcturus Therapeutics’ Kostaive, the first self-amplifying mRNA COVID-19 vaccine
14 February 2025 - Kostaive represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to ...
Posted by Michael Wonder on 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...
Posted by Michael Wonder on 28 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by EMA
27 January 2025 - If approved, the new presentation will offer a convenient administration option to healthcare professionals. ...
Posted by Michael Wonder on 05 Dec 2024
GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission
27 November 2024 - New fully liquid presentation means reconstitution is not needed before use. ...
Posted by Michael Wonder on 11 Oct 2024
Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine receives authorisation in the EU
9 October 2024 - Novavax today announced that the European Commission granted marketing authorisation for Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine ...
Posted by Michael Wonder on 25 Sep 2024
GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion
24 September 2024 - Marketing authorisation in EU expected by November 2024. ...
Posted by Michael Wonder on 20 Sep 2024
Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
19 September 2024 - MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review ...