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RSS FeedPosted by Michael Wonder on 28 Mar 2023
Amicus Therapeutics announces European Commission approval for Pombiliti in patients with late-onset Pompe disease
27 March 2023 - CHMP opinion for miglustat, the oral enzyme stabiliser component of AT-GAA, on track for 2Q, 2023. ...
Posted by Michael Wonder on 22 Mar 2023
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
Posted by Michael Wonder on 06 Mar 2023
Bristol Myers Squibb receives European Commission approval of Reblozyl (luspatercept) for anaemia in adult patients with non-transfusion-dependent beta thalassaemia
3 March 2023 - Third authorised indication in Europe for Reblozyl, a first in class treatment for patients with diseases ...
Posted by Michael Wonder on 03 Mar 2023
Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer
1 March 2023 - Approval is based on Phase 3 ARASENS trial data. ...
Posted by Michael Wonder on 27 Feb 2023
Incyte announces positive CHMP opinion for ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo in adults and adolescents
24 February 2023 - The positive CHMP opinion is based on Phase 3 data showing treatment with ruxolitinib cream resulted in ...
Posted by Michael Wonder on 27 Feb 2023
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe Crohn's disease
27 February 2023 - The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance ...
Posted by Michael Wonder on 24 Feb 2023
Highlights from the 20-23 February 2023 CHMP meeting
24 February 2023 - Eight new medicines recommended for approval ...
Posted by Michael Wonder on 24 Feb 2023
Merck and Ridgeback provide update on EU marketing authorisation application for Lagevrio (molnupiravir)
24 February 2023 - Merck and Ridgeback Biotherapeutics today announced that the CHMP of the EMA has recommended the refusal ...
Posted by Michael Wonder on 24 Feb 2023
Libtayo (cemiplimab) in combination with chemotherapy receives positive CHMP opinion for the treatment of advanced PD-L1 positive non-small cell lung cancer
24 February 2023 - Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to ...
Posted by Michael Wonder on 24 Feb 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for pegunigalsidase alfa for treatment of Fabry disease
24 February 2023 - European Commission decision anticipated in beginning of May 2023. ...
Posted by Michael Wonder on 24 Feb 2023
Janssen receives positive CHMP opinion for Akeega (niraparib and abiraterone acetate dual action tablet) plus prednisone or prednisolone for the treatment of adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer
24 February 2023 - The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the ...
Posted by Michael Wonder on 24 Feb 2023
Akebia receives positive CHMP opinion in Europe for Vafseo (vadadustat) for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
23 February 2023 - Akebia Therapeutics today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
Posted by Michael Wonder on 22 Feb 2023
Calquence tablet formulation approved in the EU for patients with chronic lymphocytic leukaemia
22 February 2023 - Approval based on ELEVATE-PLUS trials which showed bioequivalence and consistent dosing versus current capsule. ...
Posted by Michael Wonder on 21 Feb 2023
First gene therapy for haemophilia B, CSL's Hemgenix, approved by the European Commission
20 February 2023 - Hemgenix underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead ...
Posted by Michael Wonder on 08 Feb 2023
Fintepla (fenfluramine) oral solution approved in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
8 February 2023 - UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union for the treatment of ...