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RSS FeedPosted by Michael Wonder on 18 Jul 2024
Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine
15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...
Posted by Michael Wonder on 03 Jul 2024
Novavax submits application to Health Canada for updated protein-based 2024-2025 formula COVID-19 vaccine
2 July 2024 - Novavax's filing is aligned with NACI, US. FDA, EMA and WHO recommendations on vaccine composition. ...
Posted by Michael Wonder on 02 Jul 2024
Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq
1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...
Posted by Michael Wonder on 30 Jun 2024
New Zealand Pharmaceutical Schedule - 1 July 2024
1 July 2024 - July 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted 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 ...