Moderna files for FDA authorisation of its updated COVID-19 vaccine

22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...

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EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants

6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...

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Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants

30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...

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ATAGI advice on the preferential use of bivalent COVID-19 vaccines for primary vaccination of people aged 12 years or older

30 May 2023 - ATAGI has made recommendations on the use of bivalent COVID-19 vaccines as a primary course. ...

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Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU

26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...

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EMA and European medicines regulatory network lift COVID-19 business continuity status

10 May 2023 - EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully ...

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Statement from Emer Cooke on the end of the COVID-19 public health emergency

9 May 2023 - On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern ...

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Moderna’s COVID-19 vaccine Spikevax receives approval for full registration

24 April 2023 - On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, Spikevax (elasomeran), ...

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Atea Pharmaceuticals announces US FDA fast track designation granted to bemnifosbuvir, an investigational oral anti-viral, for the treatment of COVID-19

25 April 2023 - Atea Pharmaceuticals today announced that the United States FDA has granted fast track designation to bemnifosbuvir for ...

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COVID-19 vaccine safety report (6 April 2023)

6 April 2023 - To 2 April 2023, more than 44 million doses of Comirnaty (Pfizer) mRNA vaccines have been administered in ...

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AstraZeneca vaccine discontinued by Federal Government

5 April 2023 - One of the first COVID-19 jabs offered to Australians has been quietly discontinued, the Federal Government has ...

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FDA authorises Gohibic (vilobelimab) injection for the treatment of COVID-19

4 April 2023 - The FDA has issued an emergency use authorisation for the use of Gohibic (vilobelimab) injection for ...

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EMA recommends approval of Bimervax as a COVID-19 booster vaccine

30 March 2023 - The EMA’s CHMP has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a ...

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COVID-19 vaccine safety report (23 March 2023)

23 March 2023 - To 19 March 2023, more than 44 million doses have been administered in Australia, as well ...

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Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access

20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...

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