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RSS FeedPosted by Michael Wonder on 16 Jan 2025
ImmunityBio provides regulatory update on global submission for Anktiva + BCG in BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ in Europe and United Kingdom
15 January 2025 - ImmunityBio responding to requests for information from both Agencies and the potential for approval in European Union ...
Posted by Michael Wonder on 16 Jan 2025
InflaRx receives European Commission approval for Gohibic (vilobelimab) for the treatment of SARS-CoV-2 induced acute respiratory distress syndrome
15 January 2025 - InflaRx today announced that the European Commission has granted marketing authorisation under exceptional circumstances for Gohibic (vilobelimab) ...
Posted by Michael Wonder on 15 Jan 2025
Acadia Pharmaceuticals submits marketing authorisation application to the EMA for trofinetide for the treatment of Rett syndrome
14 January 2025 - Filing marks company’s first marketing authorisation application in Europe. ...
Posted by Michael Wonder on 07 Jan 2025
EMA commences review of donidalorsen in hereditary angioedema
6 January 2025 - Otsuka announces that the EMA has accepted for review the marketing authorisation application for the hereditary ...
Posted by Michael Wonder on 07 Jan 2025
Norgine submits marketing authorisation application to the EMA for eflornithine (difluoromethylornithine) in high risk neuroblastoma
6 January 2025 - Norgine today announced that it completed its marketing authorisation application filing to the EMA for eflornithine in ...
Posted by Michael Wonder on 01 Jan 2025
European Commission approves Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
30 December 2024 - In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced the risk of disease progression or ...
Posted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 24 Dec 2024
Blarcamesine receives EMA filing acceptance for treatment of Alzheimer’s disease
23 December 2024 - Submission based on favourable ANAVEX 2-73-AD-004 trial results in patients with early Alzheimer’s disease. ...
Posted by Michael Wonder on 24 Dec 2024
Cytokinetics announces EMA validation of marketing authorisation application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy
23 December 2024 - Cytokinetics today announced that the EMA has validated the marketing authorisation application for aficamten, a next in ...
Posted by Michael Wonder on 23 Dec 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
23 December 2024 - Approval based on results of the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 23 Dec 2024
Tagrisso approved in the EU for patients with unresectable EGFR mutated lung cancer
23 December 2024 - Approval based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 22 Dec 2024
Dong-A ST secures European approval for Stelara biosimilar Imuldosa
19 December 2024 - Global market expansion accelerates with back to back FDA and EC authorisations. ...
Posted by Michael Wonder on 19 Dec 2024
Gilead’s seladelpar receives positive CHMP opinion for primary biliary cholangitis
13 December 2024 - Recommendation based on the RESPONSE study which demonstrated ALP normalisation in 25% of participants at 12 months ...
Posted by Michael Wonder on 18 Dec 2024
Johnson & Johnson submits application to the EMA seeking approval of a new indication for Imbruvica (ibrutinib) in adult patients with previously untreated mantle cell lymphoma who are eligible for autologous stem cell transplant
18 December 2024 - The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with ...
Posted by Michael Wonder on 18 Dec 2024
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) designation in relapsed extensive-stage small-cell lung cancer
16 December 2024 - Regulatory designation based on promising preliminary clinical data. ...