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RSS FeedPosted 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 ...
Posted by Michael Wonder on 22 May 2026
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours
22 May 2026 - Based on three Phase 2 trials of AstraZeneca and Daiichi Sankyo’s Enhertu which showed clinically meaningful responses ...
Posted by Michael Wonder on 22 May 2026
The EMA accepts Teva’s marketing authorisation application for olanzapine long-acting injectable for the treatment of schizophrenia in adults
21 May 2026 - Teva Pharmaceuticals and Medincell today announced that the EMA has accepted the marketing authorisation application for olanzapine ...
Posted by Michael Wonder on 15 May 2026
Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes
15 May 2026 - Sandoz today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda ...
Posted by Michael Wonder on 13 May 2026
European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors
13 May 2026 - Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication ...
Posted by Michael Wonder on 08 May 2026
Bristol Myers Squibb receives European Commission approval of Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis in adults
8 May 2026 - Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone ...
Posted by Michael Wonder on 01 May 2026
OS Therapies announces EMA initiates rolling review of conditional marketing authorisation application for OST-HER2 in the prevention or delay of recurrence in fully resected pulmonary metastatic osteosarcoma
30 April 2026 - OS Therapies today announced that the EMA's Committee for Advanced Therapy, in conjunction with the CHMP and ...