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RSS FeedPosted by Michael Wonder on 13 Oct 2023
Vueway (gadopiclenol) receives positive CHMP opinion
12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
Posted by Michael Wonder on 11 Oct 2023
EMA publishes agenda for 9-12 October 2023 CHMP meeting
9 October 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 ...
Posted by Michael Wonder on 30 Sep 2023
Geron announces EMA validation of marketing authorisation application for imetelstat for the treatment of lower risk MDS
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...
Posted by Michael Wonder on 29 Sep 2023
STADA and Calliditas announce the filing for full marketing authorisation of Kinpeygo in the EU
28 September 2023 - Submission to the CHMP for full approval is based on the full two-year data set from the ...
Posted by Michael Wonder on 26 Sep 2023
Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for multiple sclerosis in Europe
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
Posted by Michael Wonder on 25 Sep 2023
AbbVie announces European Commission approval of Tepkinly (epcoritamab) for adults with relapsed or refractory diffuse large B-cell lymphoma
25 September 2023 - Conditional marketing authorisation approval from the European Commission is supported by data from the pivotal Phase 1/2 ...
Posted by Michael Wonder on 23 Sep 2023
Jazz Pharmaceuticals receives European Commission approval for Enrylaze (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 September 2023 - Jazz Pharmaceuticals today announced that the European Commission has granted marketing authorisation for Enrylaze (JZP458; a recombinant ...
Posted by Michael Wonder on 23 Sep 2023
European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention
19 September 2023 - Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral ...
Posted by Michael Wonder on 21 Sep 2023
BeiGene announces positive regulatory updates in Europe and the US after recently regaining global rights for Tevimbra
19 September 2023 - European Commission approves Tevimbra for previously treated advanced or metastatic oesophageal squamous cell carcinoma. ...
Posted by Michael Wonder on 21 Sep 2023
Biocon Biologics receives European Commission approval for Yesafili, biosimilar aflibercept
20 September 2023 - Biocon Biologics, a subsidiary of Biocon, has announced that the European Commission granted marketing authorisation in ...
Posted by Michael Wonder on 21 Sep 2023
European Commission approves Menarini Group’s Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
20 September 2023 - Orserdu is the first treatment specifically for patients with oestrogen receptor positive, HER2 negative advanced or metastatic breast ...
Posted by Michael Wonder on 21 Sep 2023
Takeda receives positive CHMP opinion for Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30+ stage III Hodgkin lymphoma in combination with AVD
18 September 2023 - Takeda announced today that the CHMP of the EMA has adopted a positive opinion for the ...