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RSS FeedPosted 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 01 Nov 2022
European Medicines Agency validates Santhera’s marketing authorisation application for vamorolone in Duchenne muscular dystrophy
31 October 2022 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorisation application for vamorolone for the treatment ...
Posted by Michael Wonder on 30 Oct 2022
Pharming announces EMA validates its marketing authorisation application under accelerated assessment for leniolisib
28 October 2022 - Marketing authorisation in the European Economic Area anticipated in H1 2023 ...
Posted by Michael Wonder on 29 Oct 2022
Almirall announces EMA acceptance for filing of marketing authorisation application for lebrikizumab in atopic dermatitis
28 October 2022 - The EMA application is based on the analysis of Phase 3 studies ADvocate 1&2 and ADhere. ...
Posted by Michael Wonder on 28 Oct 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
28 October 2022 - EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated ...
Posted by Michael Wonder on 28 Oct 2022
AbbVie announces submissions of regulatory applications for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory diffuse large B-cell lymphoma and large B-cell lymphoma
28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA. ...
Posted by Michael Wonder on 28 Oct 2022
European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV prevention
28 October 2022 - The marketing application is based on results from the HPTN 083 and 084 Phase 2b/3 studies ...
Posted by Michael Wonder on 28 Oct 2022
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...
Posted by Michael Wonder on 24 Oct 2022
European Medicines Agency grants PRIME designation to BIT Pharma’s NicaPlant for treatment of non-traumatic subarachnoid haemorrhage in patients undergoing surgery.
19 October 2022 - BIT Pharma today announced that the EMA has granted access to the Priority Medicines (PRIME) scheme for ...
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 ...
Posted by Michael Wonder on 18 Oct 2022
Kite’s Yescarta first CAR T-cell therapy to receive European marketing authorisation for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
17 October 2022 - First treatment in 30 years to improve upon standard care for second-line treatment of DLBCL. ...