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RSS FeedPosted by Michael Wonder on 24 Apr 2023
Janssen marks first approval worldwide for Akeega (niraparib and abiraterone acetate dual action tablet) with EC authorisation for the treatment of patients with metastatic castration resistant prostate cancer with BRCA1/2 mutations
21 April 2023 - Approval for Akeega is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision ...
Posted by Michael Wonder on 23 Apr 2023
EMA addresses considerations for single-arm trials
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...
Posted by Michael Wonder on 21 Apr 2023
Incyte announces European Commission approval of Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents
20 April 2023 - Phase 3 data supporting the approval show treatment with Opzelura resulted in improved facial and total body ...
Posted by Michael Wonder on 21 Apr 2023
GenSight Biologics withdraws its EMA application for Lumevoq
20 April 2023 - GenSight Biologics today announces that the Committee for Advanced Therapies (CAT) of the CHMP of the EMA ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 17 Apr 2023
AbbVie announces European Commission approval of Rinvoq (upadacitinib) for the treatment of moderately to severely active Crohn's disease
17 April 2023 - Seventh approved indication for Rinvoq in the European Union and the first and only oral janus kinase ...
Posted by Michael Wonder on 06 Apr 2023
Mirum submits for European approval of Livmarli in progressive familial intrahepatic cholestasis
5 April 2023 - Application based on statistically significant and clinically meaningful improvements in serum bile acids, pruritus, bilirubin, and growth ...
Posted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 03 Apr 2023
Sandoz receives approval by European Commission for Hyrimoz (adalimumab) high-concentration formulation
3 April 2023 - Biosimilar Hyrimoz (adalimumab) citrate free high concentration formulation is now approved in the EU for use in ...
Posted by Michael Wonder on 03 Apr 2023
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder
3 April 2023 - No relapses observed in pivotal trial of first and only long-acting C5 inhibitor, indicating potential to ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 02 Apr 2023
TG Therapeutics announces positive CHMP opinion for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
31 March 2023 - TG Therapeutics today announced that the CHMP of the EMA has issued a positive opinion recommending ...
Posted by Michael Wonder on 02 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
Posted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 01 Apr 2023
Highlights from the 27 - 30 March 2023 CHMP meeting
31 March 2023 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. ...