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RSS FeedPosted by Michael Wonder on 25 Nov 2023
Vertex announces EMA validation for marketing authorisation application extension for Kaftrio in combination with ivacaftor to include people with cystic fibrosis and responsive rare mutations
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
Posted by Michael Wonder on 25 Nov 2023
Janssen submits application to the EMA for Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR mutated non-small cell lung cancer after failure of prior therapy
23 November 2023 - The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking ...
Posted by Michael Wonder on 21 Nov 2023
Anavex initiates regulatory submission of oral blarcamesine for Alzheimer’s disease to EMA
20 November 2023 - Anavex Life Sciences announced today that representatives of Anavex met with team members of the EMA. ...
Posted by Michael Wonder on 11 Nov 2023
Bayer’s aflibercept 8 mg recommended for approval in EU
10 November 2023 - Recommendation by the CHMP based on positive results from PULSAR clinical trial in neovascular (wet) age-related macular ...
Posted by Michael Wonder on 10 Nov 2023
UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalised myasthenia gravis in Europe
10 November 2023 - The CHMP positive opinion is based on the pivotal Phase 3 MycarinG study in generalised myasthenia gravis ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
Posted by Michael Wonder on 30 Oct 2023
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
30 October 2023 - If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment ...
Posted by Michael Wonder on 30 Oct 2023
Egetis announces EMA validation of marketing authorisation application for Emcitate for the treatment of MCT8 deficiency
27 October 2023 - Egetis Therapeutics today announced that its marketing authorisation application to the EMA for Emcitate (tiratricol) for ...
Posted by Michael Wonder on 28 Oct 2023
ImmunoGen announces European Medicines Agency acceptance of marketing authorisation application for mirvetuximab soravtansine in platinum-resistant ovarian cancer
27 October 2023 - ImmunoGen today announced that the EMA has accepted the marketing authorisation application for mirvetuximab soravtansine (Elahere) ...
Posted by Michael Wonder on 26 Oct 2023
Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
Posted by Michael Wonder on 25 Oct 2023
Orphelia Pharma files EU marketing authorisation application for Kizfizo
24 October 2023 - Orphelia Pharma today announces the filing of a centralised marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 24 Oct 2023
Ipsen updates on EU marketing authorisation application for odevixibat in Alagille syndrome
23 October 2023 - Ipsen plans to submit a new marketing authorisation application for the treatment of Alagille syndrome by the ...
Posted by Michael Wonder on 11 Oct 2023
Cosmo announces submission of Winlevi to the EMA
10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, ...
Posted by Michael Wonder on 07 Oct 2023
Janssen submits application to the European Medicines Agency for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
Posted by Michael Wonder on 03 Oct 2023
Formycon and Fresenius Kabi announce EMA acceptance of the marketing authorisation application for FYB202, an ustekinumab biosimilar candidate
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...