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RSS FeedPosted by Michael Wonder on 29 Apr 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for first-line chronic lymphocytic leukaemia
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 28 Apr 2025
Lynozyfic (linvoseltamab) approved in the European Union for the treatment of relapsed/refractory multiple myeloma
28 April 2025 - Regeneron Pharmaceuticals today announced that the European Commission has granted conditional marketing approval of Lynozyfic (linvoseltamab) to ...
Posted by Michael Wonder on 28 Apr 2025
Vertex receives CHMP positive opinion for Alyftrek, a new once-daily CFTR modulator for the treatment of cystic fibrosis
28 April 2025 - In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to Kaftrio (ivacaftor/tezacaftor/elexacaftor) at ...
Posted by Michael Wonder on 28 Apr 2025
Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab for the treatment of advanced HER2 positive biliary tract cancer
25 April 2025 - Jazz Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Apr 2025
New treatment against Duchenne muscular dystrophy
25 April 2025 - Duvyzat can be used in a wide patient population from the age of six. ...
Posted by Michael Wonder on 28 Apr 2025
First treatment against severe thyroid eye disease
25 April 2025 - Tepezza significantly improves symptoms for patients with moderate to severe thyroid eye disease ...
Posted by Michael Wonder on 27 Apr 2025
Tremfya (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
25 April 2025 - Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for Tremfya (guselkumab) ...
Posted by Michael Wonder on 26 Apr 2025
CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU
25 April 2025 - Camurus today announced that the EMA's CHMP has adopted a positive opinion for market authorisation of Oczyesa, ...
Posted by Michael Wonder on 22 Apr 2025
EMA publishes agenda for 22-25 April 2025 CHMP meeting
22 April 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Apr 2025
Leqembi (lecanemab) is the first medicine that slows progression of early Alzheimer’s disease to be authorised in the European Union
15 Apil 2025 - Eisai and Biogen announced today that the European Commission has granted the amyloid-beta monoclonal antibody Leqembi (lecanemab) ...
Posted by Michael Wonder on 14 Apr 2025
European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...
Posted by Michael Wonder on 09 Apr 2025
Bayer files for approval of aflibercept 8 mg for treatment of retinal vein occlusion in EU
8 April 2025 - Bayer has submitted an application to the EMA seeking approval of aflibercept 8 mg (114.3 mg/ml solution ...
Posted by Michael Wonder on 08 Apr 2025
Datroway approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer
8 April 2025 - Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology ...
Posted by Michael Wonder on 08 Apr 2025
AbbVie announces European Commission approval of Rinvoq (upadacitinib) for the treatment of adults with giant cell arteritis
8 April 2025 - This marks the eighth approved indication for Rinvoq in the EU. ...
Posted by Michael Wonder on 08 Apr 2025
European Commission approves expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis
7 April 2025 - Approximately 4,000 people living with cystic fibrosis in the European Union are newly eligible for a ...