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RSS FeedPosted by Michael Wonder on 19 Nov 2022
European Commission approves Enjaymo (sutimlimab) for treatment of haemolytic anaemia in adult patients with cold agglutinin disease
17 November 2022 - Enjaymo is the first and only approved therapeutic option approved for haemolytic anaemia in adult patients ...
Posted by Michael Wonder on 15 Nov 2022
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...
Posted by Michael Wonder on 15 Nov 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer
14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...
Posted by Michael Wonder on 15 Nov 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
14 November 2022 - Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk ...
Posted by Michael Wonder on 12 Nov 2022
European Commission approves Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus infection and/or disease that are refractory (with or without resistance) to one or more prior therapies
11 November 2022 - Livtencity is the first and only treatment approved for this indication by the EC. ...
Posted by Michael Wonder on 11 Nov 2022
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
10 November 2022 - Pfizer and BioNTech today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Comirnaty Original/Omicron ...
Posted by Michael Wonder on 11 Nov 2022
Meeting highlights from the 7-10 November 2022 CHMP meeting
11 November 2022 - The EMA’s CHMP recommended four medicines for approval at its November 2022 meeting. ...
Posted by Michael Wonder on 11 Nov 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis
11 November 2022 - Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and ...
Posted by Michael Wonder on 11 Nov 2022
Sanofi and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission
10 November 2022 - First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe. ...
Posted by Michael Wonder on 04 Nov 2022
Beyfortus approved in the EU for the prevention of RSV lower respiratory tract disease in infants
4 November 2022 - European Commission grants first approval worldwide following positive CHMP opinion in September. ...
Posted by Michael Wonder on 03 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
2 November 2022 - Brukinsa is the first and only Bruton’s tyrosine kinase inhibitor for marginal zone lymphoma approved in the ...
Posted by Michael Wonder on 01 Nov 2022
Vaxzevria receives full marketing authorisation in the EU for the prevention of COVID-19
1 November 2022 - AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full marketing authorisation in the European Union. ...
Posted by Michael Wonder on 21 Oct 2022
Leo Pharma announces European Commission approval of Adtralza (tralokinumab) for the treatment of moderate to severe atopic dermatitis in adolescents
20 October 2022 - Adtralza, a biologic that targets and neutralises the interleukin-13 cytokine, is now approved in Europe for adolescents ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of second adapted Spikevax vaccine
19 October 2022 - The EMA’s CHMP has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 ...