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 ...

Read more →

COVID-19 vaccine available in March

22 February 2024 - Joint media release with Health New Zealand. ...

Read more →

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 ...

Read more →

MHRA approvals for Comirnaty (Pfizer/BioNTech) and Nuvaxovid (Novavax) COVID-19 vaccines

10 February 2024 - Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn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. ...

Read more →

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 ...

Read more →

Texas makes a stand against big pharma’s Covid vaccines

19 December 2023 - On the last day of November Texas launched extraordinary legal proceedings that could have wide-ranging political ...

Read more →

Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk

12 December 2023 - Submission supported by positive results of a Phase 3 study showing immune response and safety in adults ...

Read more →

Evolving our approach to COVID-19 vaccines and treatments

6 December 2023 - As New Zealand’s response to the COVID-19 pandemic has evolved, so has ours. ...

Read more →

EU medicines agencies reflect on lessons learned from COVID-19

1 December 2023 - The European Medicines Regulatory Network has been at the forefront of the fight against COVID-19 with ...

Read more →