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RSS FeedPosted by Michael Wonder on 28 Jun 2024
2024-25 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
28 June 2024 - 2024-25 PBS) and NIP cost recovery fees commence on 1 July 2024. ...
Posted by Michael Wonder on 28 Jun 2024
Pfizer and BioNTech receive positive CHMP opinion for omicron JN.1 adapted COVID-19 Vaccine in the European Union
27 June 2024 - The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for ...
Posted by Michael Wonder on 27 Jun 2024
Bavarian Nordic submits marketing authorisation application for its chikungunya vaccine candidate to EMA
26 June 2024 - Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by ...
Posted by Michael Wonder on 25 Jun 2024
Novavax submits application to EMA for updated protein-based 2024-2025 formula COVID-19 vaccine
24 June 2024 - Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 ...
Posted by Michael Wonder on 25 Jun 2024
Valneva announces Health Canada approval of the world’s first chikungunya vaccine, Ixchiq
24 June 2024 - Valneva today announced that Health Canada has approved Ixchiq, Valneva’s single-dose vaccine for the prevention of ...
Posted by Michael Wonder on 21 Jun 2024
Outcomes from the May 2024 PBAC intracycle meeting
21 June 2024 - Recommendations made by the PBAC in May 2024 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 18 Jun 2024
US FDA approves Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
17 June 2024 - Capvaxive (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal ...
Posted by Michael Wonder on 17 Jun 2024
Bavarian Nordic completes BLA submission to US FDA for its Chikungunya vaccine candidate
17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...
Posted by Michael Wonder on 15 Jun 2024
Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine
14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...
Posted by Michael Wonder on 09 Jun 2024
US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk
7 June 2024 - Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of ...
Posted by Michael Wonder on 08 Jun 2024
Moderna files FDA application for the JN.1 targeting COVID-19 vaccine
7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...
Posted by Michael Wonder on 08 Jun 2024
Updated COVID-19 vaccines for use in the United States beginning in fall 2024
7 June 2024 - The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 5 June 2024 to ...
Posted by Michael Wonder on 03 Jun 2024
Bavarian Nordic submits supplemental BLA seeking US FDA approval of freeze dried formulation of smallpox and mpox vaccine
31 May 2024 - Bavarian Nordic today announced the submission of a supplemental biologics license application to the US FDA ...
Posted by Michael Wonder on 01 Jun 2024
First vaccine to protect adults from Chikungunya
31 May 2024 - EMA has recommended granting a marketing authorisation in the European Union for Ixchiq, the first vaccine ...
Posted by Michael Wonder on 31 May 2024
Moderna receives US FDA approval for RSV vaccine mRESVIA
31 May 2024 - mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes ...