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RSS FeedPosted by Michael Wonder on 21 Jul 2023
Emergent BioSolutions receives US FDA approval of Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, a two dose anthrax vaccine for post-exposure prophylaxis use
20 July 2023 - Emergent has been delivering Cyfendus vaccine to the US Department of Health and Human Services since ...
Posted by Michael Wonder on 17 Jul 2023
Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5
13 July 2023 - Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5 ...
Posted by Michael Wonder on 11 Jul 2023
Takeda withdraws US application for dengue vaccine candidate
11 July 2023 - Takeda said on Tuesday it was voluntarily withdrawing its application for its dengue vaccine candidate, following ...
Posted by Michael Wonder on 11 Jul 2023
MHRA authorises GSK’s Arexvy, the first respiratory syncytial virus vaccine for older adults
10 July 2023 - The authorisation is based on phase III efficacy data in older adults. ...
Posted by Michael Wonder on 06 Jul 2023
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...
Posted by Michael Wonder on 05 Jul 2023
Global regulators confirm good safety profile of COVID-19 vaccines
5 July 2023 - EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the ...
Posted by Michael Wonder on 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
Posted by Michael Wonder on 03 Jul 2023
Older Americans can get RSV vaccine this fall after consulting their doctor, CDC says
29 June 2023 - Americans 60 and older can get a new RSV vaccine but should discuss it with their ...
Posted by Michael Wonder on 01 Jul 2023
Changes to the National Immunisation Program effective 1 July 2023
30 June 2023 - From 1 July 2023, Vaxelis will be added to the National Immunisation Program as an alternative ...
Posted by Michael Wonder on 30 Jun 2023
Moderna initiates rolling submission to Health Canada for updated COVID-19 vaccine
29 June 2023 - Health Canada submission follows international recommendations to develop monovalent XBB.1.5 COVID-19 vaccines. ...
Posted by Michael Wonder on 28 Jun 2023
2023-24 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
28 June 2023 - 2023-24 Pharmaceutical Benefits Scheme and National Immunisation Program cost recovery fees commence on 1 July 2023. ...
Posted by Michael Wonder on 27 Jun 2023
AC Immune receives FDA fast track designation for anti-amyloid beta active immunotherapy, ACI-24.060, to treat Alzheimer’s disease
27 June 2023 - Initial PET data on amyloid plaque reduction in Alzheimer's disease expected H1, 2024. ...
Posted by Michael Wonder on 27 Jun 2023
GSK receives US FDA fast track designation for investigational vaccine against gonorrhoea
27 June 2023 - Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to ...
Posted by Michael Wonder on 26 Jun 2023
Japan’s Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over
26 June 2023 - Shingrix (recombinant zoster vaccine) is already approved in Japan for adults aged 50 and over. ...
Posted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...