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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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Japan's Ministry of Health, Labour and Welfare approves CSL and Arcturus Therapeutics' ARCT-154, the first self-amplifying mRNA vaccine approved for COVID in adults

27 November 2023 - Exclusive Partner in Japan, Meiji Seika Pharma advances regulatory approval. ...

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FDA fast track designation granted for Vaxinia trial program

28 November 2023 - FDA fast track designation for bile duct cancer granted for CF33-hNIS (Vaxinia) MAST clinical program. ...

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Daichirona for intramuscular injection for booster vaccination approved in Japan as Omicron XBB.1.5 adapted monovalent mRNA vaccine against COVID-19

28 November 2023 - - Daiichi Sankyo today announced that Daichirona for intramuscular injection (DS-5670) for booster vaccination has been ...

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EMA accepts Valneva’s Chikungunya vaccine marketing authorisation application for accelerated assessment

27 November 2023 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...

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New Covid-19 vaccines available to target current variants

20 November 2023 - The Australian Government has accepted the latest advice from the Australian Technical Advisory Group on Immunisation on ...

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FDA approves first vaccine to prevent disease caused by chikungunya virus

9 November 2023 - Today, the US FDA approved Ixchiq, the first chikungunya vaccine.  ...

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The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture

1 November 2023 - After holding oversight roles for covid vaccines, two regulators from the US FDA went to work for ...

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National Immunisation Program – changes to shingles vaccination from today

1 November 2023 - From today, the shingles vaccine Shingrix has replaced Zostavax on the National Immunisation Program schedule for ...

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EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5

31 October 2023 - The EMA’s CHMP has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of ...

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Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment

25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...

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