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RSS FeedPosted 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. ...
Posted by Michael Wonder on 18 Nov 2023
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma
17 November 2023 - Approval was based on results from the ROSEWOOD trial in which Brukinsa plus the anti-CD20 monoclonal ...
Posted by Michael Wonder on 18 Nov 2023
Almirall receives European Commission Approval of Ebglyss (lebrikizumab) for moderate to severe atopic dermatitis
17 November 2023 - Following the European Commission approval, Germany is the first country where lebrikizumab will be available for prescription. ...
Posted by Michael Wonder on 15 Nov 2023
Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
14 November 2023 - If approved, Tecentriq subcutaneous would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment ...
Posted by Michael Wonder on 13 Nov 2023
MediWound receives positive CHMP opinion recommending approval for NexoBrid to treat paediatric patients
13 November 2023 - The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment ...
Posted by Michael Wonder on 13 Nov 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
13 November 2023 - If approved, momelotinib will become the first and only treatment in the EU specifically indicated for myelofibrosis ...
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 11 Nov 2023
Highlights from the 6-9 November 2023 CHMP meeting
10 November 2023 - The EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting. ...