Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 31 May 2024
Highlights from the 27-30 May 2024 CHMP meeting
31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...
Posted by Michael Wonder on 23 May 2024
Pfizer announces availability of Abrysvo in Canada for immunisation of pregnant individuals and adults 60+
22 May 2024 - Availability of Arbysvo is a major step in protecting infants and adults 60 years of age ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 05 May 2024
PHARMAC and Health NZ weigh up future of COVID-19 vaccines and treatments
3 May 2024 - PHARMAC and Health NZ are weighing up the future direction of COVID-19 vaccinations and treatments in ...
Posted by Michael Wonder on 03 May 2024
Agenda for the May 2024 PBAC meeting
3 May 2024 - The agenda for next week's PBAC meeting is now available. Robyn Ward's first meeting as the ...
Posted by Michael Wonder on 01 May 2024
Bavarian Nordic initiates rolling submission of biologics license application with FDA for its Chikungunya vaccine candidate
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 22 Apr 2024
Boost for pharmacists for flu season
20 April 2024 - The Albanese Government is protecting Australians in aged care and disability homes by funding pharmacists for the ...
Posted by Michael Wonder on 18 Apr 2024
COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 16 Apr 2024
GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...