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RSS FeedPosted 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 ...
Posted by Michael Wonder on 28 Apr 2026
GSK’s investigational liver therapy, efimosfermin, receives US FDA breakthrough therapy and EMA Priority Medicines (PRIME) designations for MASH
27 April 2026 - GSK today announced that efimosfermin, a once monthly investigational liver therapy, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 27 Apr 2026
Novartis Rhapsido receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria
27 April 2026 - Novartis announced today that the European Commission approved Rhapsido (remibrutinib) for chronic spontaneous urticaria in adult patients ...
Posted by Michael Wonder on 25 Apr 2026
Highlights from 20-23 April 2026 CHMP meeting
24 April 2026 - The EMA’s CHMP recommended five medicines for approval at its April 2026 meeting. ...
Posted by Michael Wonder on 25 Apr 2026
Novartis withdraws EMA application for adding new indication for Pluvicto
24 April 2026 - Novartis has withdrawn a EMA type II variation application for Pluvicto to treat adult patients with prostate-specific ...