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RSS FeedPosted by Michael Wonder on 17 Sep 2022
CHMP adopts positive opinion to extend indication of Veklury (remdesivir) for the treatment of paediatric patients with COVID-19
16 September 2022 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment for ...
Posted by Michael Wonder on 13 Sep 2022
Novavax Nuvaxovid COVID-19 vaccine granted expanded conditional marketing authorisation in the European Union for use as a booster for adults aged 18 and older
12 September 2022 - Nuvaxovid is now authorised in the EU for use in adults aged 18 and older as ...
Posted by Michael Wonder on 12 Sep 2022
Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
12 September 2022 - The EMA’s CHMP has recommended authorising an adapted bivalent vaccine targeting the Omicron sub-variants BA.4 and ...
Posted by Michael Wonder on 07 Sep 2022
EMA refused rolling review of SK Bioscience's COVID-19 vaccine
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
Posted by Michael Wonder on 06 Sep 2022
ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
6 September 2022 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 01 Sep 2022
EMA CHMP adopts positive opinion recommending authorisation for the use of Moderna's Omicron targeting bivalent booster in the European Union
1 September 2022 - Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 sub-variants when ...
Posted by Michael Wonder on 01 Sep 2022
First adapted COVID-19 booster vaccines recommended for approval in the EU
1 September 2022 - The EMA’s CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19. ...
Posted by Michael Wonder on 27 Aug 2022
Pfizer and BioNTech complete submission to EMA for Omicron BA.4/BA.5 adapted bivalent vaccine
26 August 2022 - Submission follows application for Omicron BA.1 adapted bivalent vaccine submitted in July. ...
Posted by Michael Wonder on 18 Aug 2022
EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine
18 August 2022 - The EMA’s CHMP has started a review of a conditional marketing authorisation application for Skycovion, a ...
Posted by Michael Wonder on 10 Aug 2022
EU regulator begins review of Pfizer-BioNTech's variant adapted COVID shot
9 August 2022 - The EMA has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, ...
Posted by Michael Wonder on 02 Aug 2022
SK bioscience submits application for conditional marketing authorisation of COVID-19 vaccine, SKYCovion to European Medicines Agency
1 August 2022 - SK bioscience will accelerate to apply for emergency use listing to the World Health Organization. ...
Posted by Michael Wonder on 28 Jul 2022
EMA reviewing data on sabizabulin for COVID-19
27 July 2022 - The EMA’s Emergency Task Force has started a review of data on the use of sabizabulin ...
Posted by Michael Wonder on 23 Jul 2022
CHMP adopts positive opinion recommending Veklury (remdesivir) receive full marketing authorisation for the treatment of patients with COVID-19
22 July 2022 - If Granted by the European Commission, Veklury will become the only direct-acting antiviral with full marketing authorisation ...
Posted by Michael Wonder on 23 Jul 2022
EMA CHMP recommends use of the Moderna COVID-19 booster in adolescents (12-17 Years) in the European Union
22 July 2022 - Moderna today announced that the EMA's CHMP has adopted a positive opinion recommending a variation to ...