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RSS FeedPosted 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. ...
Posted by Michael Wonder on 27 Mar 2024
EU recommendations for 2024/2025 seasonal flu vaccine composition
26 March 2024 - EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for ...
Posted by Michael Wonder on 16 Mar 2024
ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment
15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...
Posted by Michael Wonder on 14 Mar 2024
European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
Posted by Michael Wonder on 04 Mar 2024
COVID-19 2024 vaccine advice
29 February 2024 - The Australian Government has accepted the latest advice from the Australian Technical Advisory Group on Immunisation ...
Posted by Michael Wonder on 29 Feb 2024
New Zealand Pharmaceutical Schedule - 1 March 2024
1 March 2024 - The March 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...