Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2023
European Commission approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma
8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...
Posted by Michael Wonder on 05 Dec 2023
Relaunched EMA website now live
5 December 2023 - EMA has relaunched its website: www.ema.europa.eu. ...
Posted by Michael Wonder on 04 Dec 2023
UCB announces European Commission approval of Zilbrysq (zilucoplan) for the treatment of adults with generalised myasthenia gravis
4 December 2023 - Approval supported by pivotal Phase 3 RAISE study in generalised myasthenia gravis which demonstrated treatment with zilucoplan ...
Posted by Michael Wonder on 27 Nov 2023
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
Posted by Michael Wonder on 27 Nov 2023
Krystal Biotech announces EMA validation of marketing authorisation application for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
27 November 2023 - Vyjuvek received orphan drug designation and PRIME designation from the EMA. ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted 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 23 Nov 2023
Praxis Precision Medicines receives PRIME designation from the EMA for elsunersen (PRAX-222) for treatment of SCN2A gain of function developmental epilepsies
16 November 2023 - IRE) -- Praxis Precision Medicines today announced that the EMA has awarded its Priority Medicines (PRIME) designation ...
Posted by Michael Wonder on 23 Nov 2023
European Commission approves Kaftrio in combination with ivacaftor for the treatment of children with cystic fibrosis ages 2 through 5
23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...
Posted by Michael Wonder on 22 Nov 2023
EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment
21 November 2023 - The European Commission has approved pharmaand’s Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer ...
Posted by Michael Wonder on 21 Nov 2023
Sandoz launches Hyrimoz (adalimumab) high concentration formulation in Europe, aiming to improve patient care
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
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 21 Nov 2023
Ascendis Pharma announces European Commission approval of Yorvipath (palopegteriparatide) for the treatment of adults with chronic hypoparathyroidism
20 November 2023 - Ascendis plans its first EU launch of Yorvipath in Germany in January 2024. ...
Posted by Michael Wonder on 18 Nov 2023
Halozyme announces argenx receives European Commission approval of Vvyvart SC with Enhanze for generalised myasthenia gravis
16 November 2023 - Vyvgart SC now approved for subcutaneous administration, adding to the already approved IV administration. ...