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RSS FeedPosted by Michael Wonder on 26 Jun 2026
European Commission approves Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as first PD-1 inhibitor plus antibody-drug conjugate regimen for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer
24 June 2026 - Approval based on results from the Phase 3 KEYNOTE-905 trial in which perioperative Keytruda plus Padcev ...
Posted by Michael Wonder on 24 Jun 2026
Cemdisiran regulatory submissions accepted for review by FDA and EMA for the treatment of generalised myasthenia gravis
22 June 2026 - Regeneron Pharmaceuticals today announced that both the US FDA and EMA have accepted the regulatory applications for ...
Posted by Michael Wonder on 24 Jun 2026
Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability targeting medicine for secondary progressive multiple sclerosis without relapses
23 June 2026 - The European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis without relapses ...
Posted by Michael Wonder on 23 Jun 2026
ViiV Healthcare advances paediatric HIV regulatory submissions with FDA priority review for Tivicay PD and EMA validation of marketing application for Tivicay
22 June 2026 - ViiV Healthcare today announced that the US FDA has accepted the supplemental new drug application to ...
Posted by Michael Wonder on 23 Jun 2026
Laboratoires Pierre Fabre receives European Commission approval for Braftovi (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer
22 June 2026 - Laboratoires Pierre Fabre announced today that the European Commission has approved Braftovi (encorafenib) in combination with cetuximab ...
Posted by Michael Wonder on 23 Jun 2026
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis
23 June 2026 - AbbVie today announced that the European Commission has approved Skyrizi (risankizumab) for the treatment of children and ...
Posted by Michael Wonder on 23 Jun 2026
Arrowhead Pharmaceuticals receives marketing authorisation in the European Union for Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
22 June 2026 - Arrowhead Pharmaceuticals today announced that the European Commission has formally granted marketing authorization for Redemplo (plozasiran), ...
Posted by Michael Wonder on 23 Jun 2026
AbbVie announces European Commission approval of Maviret (glecaprevir/pibrentasvir) for people with acute hepatitis C virus infection
23 June 2026 - AbbVie today announced that the European Commission approved Maviret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral therapy for ...
Posted by Michael Wonder on 23 Jun 2026
European Commission approves Trodelvy as a first-line treatment for metastatic triple negative breast cancer patients not candidates for PD-(L)1 inhibitors
23 June 2026 - Gilead Sciences today announced that the European Commission has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) ...
Posted by Michael Wonder on 15 Jun 2026
Oncopeptides submits type II variation application to EMA for Pepaxti label expansion into third-line treatment
12 June 2026 - Oncopeptides today announces that it has formally submitted its type II variation application to the EMA. ...
Posted by Michael Wonder on 10 Jun 2026
EMA confirms asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke
10 June 2026 - Bayer today announced that the EMA has positively validated and begun assessing the company’s marketing authorisation ...
Posted by Michael Wonder on 09 Jun 2026
Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector
8 June 2026 - The European Commission has approved Sarclisa (isatuximab) subcutaneous in combination with standard of care regimens for the ...
Posted by Michael Wonder on 06 Jun 2026
Chiesi Global Rare Diseases announces European Commission approval of Lojuxta (lomitapide) capsules for paediatric use in homozygous familial hypercholesterolaemia
5 June 2026 - Chiesi Global Rare Diseases today announced that the European Commission has approved lomitapide capsules for use in ...
Posted by Michael Wonder on 06 Jun 2026
IntraBio announces submission of variation application to the EMA for Aqneursa for ataxia-telangiectasia
5 June 2026 - IntraBio Inc. today announced the submission of a variation application to the EMA to expand the ...
Posted by Michael Wonder on 04 Jun 2026
European Commission approves Amgen's Imdylltra for the treatment of extensive-stage small cell lung cancer
1 June 2026 - Amgen today announced that the European Commission has granted marketing authorisation for Imdylltra (tarlatamab) as a ...