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RSS FeedPosted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 21 Jan 2022
International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 10 Jan 2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
Posted by Michael Wonder on 26 Dec 2021
Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA
23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...
Posted by Michael Wonder on 20 Dec 2021
EMA recommends Nuvaxovid for authorisation in the EU
20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...
Posted by Michael Wonder on 16 Dec 2021
EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
16 December 2021 - Rolling review starts in parallel ...
Posted by Michael Wonder on 16 Dec 2021
COVID-19: EMA recommends authorisation of antibody medicine Xevudy
16 December 2021 - EMA’s CHMP has recommended authorising the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19. ...
Posted by Michael Wonder on 16 Dec 2021
EMA recommends approval for use of Kineret in adults with COVID-19
16 December 2021 - EMA’s CHMP has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in ...
Posted by Michael Wonder on 15 Dec 2021
COVID-19 Vaccine Janssen: EMA recommendation on booster dose
15 December 2021 - EMA’s CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at ...
Posted by Michael Wonder on 14 Dec 2021
EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
14 December 2021 - Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio ...
Posted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 08 Dec 2021
Novavax COVID-19 vaccine could be approved very soon, says EMA chief
8 December 2021 - The head of the EMA on Tuesday said that it could soon approve the COVID-19 vaccine ...