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RSS FeedPosted 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
ViiV Healthcare announces CHMP positive opinion for Vocabria + Rekambys, the first and only complete long-acting HIV treatment, for adolescents in Europe
16 December 2024 - Vocabria + Rekambys (cabotegravir + rilpivirine) is the first and only complete long-acting regimen for the treatment ...
Posted by Michael Wonder on 18 Dec 2024
Geron announces positive CHMP opinion for Rytelo (imetelstat) for the treatment of adults with transfusion-dependent anaemia due to lower-risk MDS
13 December 2024 - Geron Corporation today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 16 Dec 2024
CHMP recommends approval of Galderma’s nemolizumab for moderate to severe atopic dermatitis and prurigo nodularis in the European Union
13 December 2024 - Nemolizumab is a first in class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling ...
Posted by Michael Wonder on 16 Dec 2024
CSL receives positive CHMP opinion for garadacimab in hereditary angioedema
13 December 2024 - If approved, garadacimab will be the first and only once monthly treatment inhibiting factor XIIa to ...
Posted by Michael Wonder on 16 Dec 2024
Celltrion receives positive CHMP opinion for three biosimilars in the European Union
15 December 2024 - The CHMP adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), ...
Posted by Michael Wonder on 16 Dec 2024
EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara
15 December 2024 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of Yesintek, ...
Posted by Michael Wonder on 14 Dec 2024
First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
13 December 2024 - Emcitate can be used in patients of all ages. ...
Posted by Michael Wonder on 14 Dec 2024
First treatment recommended for rare progressive lung conditions in children and adolescents
13 December 2024 - The EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive ...
Posted by Michael Wonder on 14 Dec 2024
First medicine to treat rare genetic disorder causing cysts and tumours
13 December 2024 - Oral medicine to treat two different conditions, rare von Hippel-Lindau disease and advanced clear cell renal cell ...
Posted by Michael Wonder on 14 Dec 2024
Highlights from the 9-12 December 2024 CHMP meeting
13 December 2024 - The EMA’s CHMP recommended seventeen medicines for approval at its December 2024 meeting. ...
Posted by Michael Wonder on 14 Dec 2024
Roche’s Vabysmo pre-filled syringe approved in the EU for three retinal conditions that can cause blindness
13 December 2024 - Vabysmo PFS is the first and only pre-filled syringe containing a bi-specific antibody, offering a convenient alternative ...