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RSS FeedPosted 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 21 May 2026
Allergan Aesthetics receives positive CHMP opinion for Boey (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adults
21 May 2026 - Positive opinion is supported by data from two pivotal Phase 3 trials, which demonstrated rapid results as ...
Posted by Michael Wonder on 20 May 2026
EMA publishes agenda for 18-21 May 2026 CHMP meeting
18 May 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 ...
Posted by Michael Wonder on 01 May 2026
Ray Therapeutics granted Priority Medicines (PRIME) designation from the EMA for RTx-015 in retinitis pigmentosa
29 April 2026 - PRIME designation follows recent FDA regenerative medicine advanced therapy designation, continues regulatory momentum for RTx-015. ...
Posted by Michael Wonder on 30 Apr 2026
European Commission approves Henlius and Organon's Poherdy (pertuzumab), the first approved biosimilar to Perjeta (pertuzumab) in Europe
29 April 2026 - Shanghai Henlius Biotech, and Organon today announced the European Commission has granted marketing authorization for Poherdy (pertuzumab) ...
Posted by Michael Wonder on 30 Apr 2026
Richter receives European Commission approval for Tuyory, its biosimilar tocilizumab in multiple indications
29 April 2026 - Gedeon Richter announces today that the European Commission granted marketing authorisation for Tuyory, its biosimilar to ...
Posted by Michael Wonder on 30 Apr 2026
Norgine announces European Commission marketing authorisation for Xolremdi (mavorixafor), the first authorised treatment for patients with WHIM syndrome in the European Union
29 April 2026 - Norgine today announced that the European Commission has granted marketing authorisation for mavorixafor as Xolremdi following a ...