Blog
RSS FeedPosted by Michael Wonder on 21 Jan 2025
Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama
20 January 2025 - Teva Pharmaceuticals will semi-exclusively market FYB203 under the brand name Ahzantive in major parts of Europe. ...
Posted by Michael Wonder on 20 Jan 2025
European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer
20 January 2025 - Expanded approval includes MMRp/MSS tumours, which represent approximately 75% of endometrial cancer cases. ...
Posted by Michael Wonder on 18 Jan 2025
Illuccix receives European approval
17 January 2025 - Telix today announces that it has received a positive decision on the marketing authorisation application for ...
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 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 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, ...