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RSS FeedPosted by Michael Wonder on 01 Apr 2026
Oculis announces EMA PRIME designation for privosegtor, advancing a potential first in class neuroprotective candidate for optic neuritis
31 March 2026 - Decision supported by positive Phase 2 ACUITY data showing substantial improvements in vision combined with anatomical and ...
Posted by Michael Wonder on 01 Apr 2026
Henlius receives two positive CHMP opinions for serplulimab, advancing global regulatory progress
30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), ...
Posted by Michael Wonder on 31 Mar 2026
European Commission approves Kygevi (doxecitine and doxribtimine) as first and only treatment for thymidine kinase 2 deficiency
31 March 2026 – UCB today announced that the European Commission has granted marketing authorisation under exceptional circumstances for Kygevi ...
Posted by Michael Wonder on 31 Mar 2026
Savara announces EMA validation of marketing authorisation application for Molbreevi in auto-immune pulmonary alveolar proteinosis
30 March 2026 - Savara today announced that the EMA has validated the submission of the Molbreevi marketing authorisation application ...
Posted by Michael Wonder on 31 Mar 2026
EMA validates indication extension application for Tryngolza (olezarsen) for the treatment of severe hypertriglyceridaemia
30 March 2026 - Sobi today announced that the EMA has validated an indication extension application for Tryngolza (olezarsen) for ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 28 Mar 2026
Johnson & Johnson’s Darzalex (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
27 March 2026 - Johnson & Johnson today announced that the CHMP of the EMA has granted approval for a Type ...
Posted by Michael Wonder on 28 Mar 2026
Sanofi’s Sarclisa subcutaneous formulation administered via on body injector recommended for EU approval by the CHMP to treat multiple myeloma
27 March 2026 - Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared ...
Posted by Michael Wonder on 28 Mar 2026
Richter receives European Commission approval for Fylrevy (estetrol tablet) as hormonal replacement therapy
27 March 2026 - Gedeon Richter announces today that the European Commission granted approval for the marketing authorisation of Fylrevy (estetrol; ...
Posted by Michael Wonder on 28 Mar 2026
Bavarian Nordic submits data to EMA to extend mpox and smallpox vaccine approval to children aged 2-11 years
27 March 2026 - Submission based on topline data from clinical study, demonstrating a comparable safety profile and a non-inferior immune ...
Posted by Michael Wonder on 28 Mar 2026
Bepirovirsen accepted for review by the EMA as a potential first in class treatment for chronic hepatitis B
27 March 2026 - Submission supported by statistically significant and clinically meaningful functional cure rates in pivotal PhIII B-Well trials. ...
Posted by Michael Wonder on 27 Mar 2026
Eisai and Nuvation Bio announce marketing authorisation application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer validated by the EMA
26 March 2026 - Additional filings are planned for the UK, Canada and other regions included in Eisai's licensed territories. ...
Posted by Michael Wonder on 26 Mar 2026
UCB receives positive CHMP opinion for new Zilbrysq (zilucoplan) pre-filled pen in EU for adults living with generalised myasthenia gravis
26 March 2026 - UCB today announced that the CHMP of the EMA has issued a positive opinion recommending a ...
Posted by Michael Wonder on 25 Mar 2026
Anavex Life Sciences provides update on regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease
25 March 2026 - Anavex Life Sciences today announced that it has withdrawn its application for the marketing authorisation of ...
Posted by Michael Wonder on 23 Mar 2026
EMA publishes agenda for 23-26 March 2026 CHMP meeting
23 March 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...