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RSS FeedPosted by Michael Wonder on 03 Aug 2023
US FDA approves Merck’s Ervebo (Ebola Zaire vaccine, live) for use in children 12 months of age and older
3 August 2023 - Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease. ...
Posted by Michael Wonder on 24 Jul 2023
First RSV vaccine to protect infants up to 6 months of age and older adults
21 July 2023 - EMA has recommended granting a marketing authorisation in the European Union for Abrysvo, a vaccine to protect ...
Posted 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 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 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 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 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 ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 08 Jun 2023
European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
7 June 2023 - The authorisation is based on Phase 3 efficacy data in older adults. ...
Posted by Michael Wonder on 06 Jun 2023
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...