Blog
RSS FeedPosted 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 27 Feb 2024
GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk
26 February 2024 - Submission supported by positive results of a Phase 3 study showing immune response and tolerability in adults ...
Posted by Michael Wonder on 13 Feb 2024
CAN-3110 receives FDA fast track designation for treatment of recurrent high-grade glioma
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
Posted by Michael Wonder on 07 Feb 2024
GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk
6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...
Posted by Michael Wonder on 05 Feb 2024
Ultimovacs receives FDA fast track designation for UV1 cancer vaccine for the treatment of patients with unresectable mesothelioma
5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical ...
Posted by Michael Wonder on 30 Jan 2024
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA for the prevention of RSV disease in adults aged 50-59 at increased risk
29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability ...
Posted by Michael Wonder on 23 Jan 2024
TGA approves RSV vaccine for use through private prescription for Australians over 60
17 January 2024 - A vaccine for respiratory syncytial virus has been approved by the TGA and will be available through ...
Posted by Michael Wonder on 06 Jan 2024
Health Canada approves Pfizer's bivalent respiratory syncytial virus vaccine for older adults and infants through maternal immunisation
4 January 2024 - Abrysvo is the only RSV vaccine authorised in Canada for maternal immunisation. ...
Posted by Michael Wonder on 28 Dec 2023
Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn
18 December 2023 - The manufacturer Novavax is no longer pursuing marketing authorisation for its COVID-19 vaccine in Switzerland. ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21 valent pneumococcal conjugate vaccine specifically designed to protect adults
19 December 2023 - The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in ...