Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 04 Jun 2026
AbbVie announces European Commission approval of Aquipta (atogepant) for the acute treatment of migraine in adults
2 June 2026 - AbbVie today announced that the European Commission has approved Aquipta (atogepant) for the acute treatment of migraine ...
Posted by Michael Wonder on 02 Jun 2026
Zepzelca (lurbinectedin) in combination with atezolizumab approved by the European Commission as first-line maintenance therapy for extensive-stage small cell lung cancer
1 June 2026 - Immedica today announces that the European Commission has granted marketing authorisation for Zepzelca (lurbinectedin), in combination with ...
Posted by Michael Wonder on 01 Jun 2026
Bristol Myers Squibb announces Opdivo (nivolumab) in combination with AVD receives expanded EU label with approval in frontline advanced classical Hodgkin lymphoma
1 June 2026 - Bristol Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) in combination with ...
Posted by Michael Wonder on 01 Jun 2026
AbbVie announces European Commission authorisation of expanded label for Venclyxto (venetoclax) to include additional combinations in previously untreated chronic lymphocytic leukaemia
29 May 2026 - AbbVie today announced that the European Commission (EC) has authorised an expanded label for Vencylxto (venetoclax) to ...
Posted by Michael Wonder on 26 May 2026
Avanzanite Bioscience’s partner Agios announces Pyrukynd (mitapivat) approval in the European Union for adults with thalassaemia
22 May 2026 - Avanzanite Bioscience today reported that its partner, Agios Pharmaceuticals announced that the European Commission has granted marketing ...
Posted by Michael Wonder on 25 May 2026
First oral GLP-1 treatment for weight management
22 May 2026 - EMA has recommended an extension to the marketing authorisation for Wegovy (semaglutide) in the EU to add ...
Posted by Michael Wonder on 22 May 2026
Otarmeni (lunsotogene parvec) receives EMA filing acceptance for genetic hearing loss
22 May 2026 - Regeneron Pharmaceuticals today announced the EMA has accepted for review under accelerated assessment the marketing authorisation application ...
Posted by Michael Wonder on 22 May 2026
Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer
22 May 2026 - Recommendation based on SERENA-6 Phase 3 trial results which showed combination reduced the risk of disease progression ...
Posted by Michael Wonder on 22 May 2026
AbbVie announces positive CHMP opinion for Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C infection
22 May 2026 - The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and ...