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RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 Jul 2022
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
Posted by Michael Wonder on 19 Jul 2022
EU regulator reviews Pfizer-BioNTech COVID shot in children as young as 6 months
18 July 2022 - The European Medicines Agency on Monday started reviewing a low-dose version of BioNTech and Pfizer’s COVID-19 ...
Posted by Michael Wonder on 11 Jul 2022
ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
11 July 2022 - The European Centre for Disease Prevention and Control and the EMA are recommending that second booster ...
Posted by Michael Wonder on 10 Jul 2022
Novavax Nuvaxovid COVID-19 vaccine conditionally authorised in the European Union for adolescents aged 12 through 17
5 July 2022 - Nuvaxovid COVID-19 vaccine is the first protein-based option for adolescents aged 12 through 17 in Europe. ...
Posted by Michael Wonder on 10 Jul 2022
Pfizer and BioNTech submit a variation to EMA for the vaccination of children 6 months to less than 5 years with Comirnaty
8 July 2022 - y 8, 2022 — Pfizer and BioNTech today announced that the companies have submitted a variation to ...
Posted by Michael Wonder on 04 Jul 2022
Global regulators agree on key principles on adapting vaccines to tackle virus variants
1 July 2022 - On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 20 Jun 2022
EFPIA and Vaccines Europe are deeply disappointed about the decision taken by World Trade Organization at the Ministerial Conference to endorse a TRIPS waiver for COVID-19 vaccines
17 June 2022 - Speaking about the waiver, EFPIA Director General, Nathalie Moll said. “The decision is a serious retrograde step ...
Posted by Michael Wonder on 19 Jun 2022
Start of rolling review for adapted Spikevax COVID-19 vaccine
17 June 2022 - EMA has started a rolling review for a version of Spikevax adapted to provide better protection ...
Posted by Michael Wonder on 15 Jun 2022
Start of rolling review for adapted Comirnaty COVID-19 vaccine
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...
Posted by Michael Wonder on 08 Jun 2022
EMA adopts first list of critical medicines for COVID-19
8 June 2022 - On 7 June 2022, the EMA’s Medicines Shortages Steering Group adopted the list of critical medicines for ...
Posted by Michael Wonder on 19 May 2022
EMA accepts filing of marketing authorisation application for Valneva’s inactivated COVID-19 vaccine candidate
19 May 2022 - 2022 – Valneva today confirmed that the EMA has accepted the filing of a marketing authorisation ...