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RSS FeedPosted by Michael Wonder on 27 Apr 2023
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
26 April 2023 - The recommendation is based on results from the Phase I/II NP30179 study, where Columvi given as a ...
Posted by Michael Wonder on 27 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 April 2023 - Recommendation based on positive Phase 3 EXPLORER-HCM and VALOR-HCM trials demonstrating benefit in patients receiving Camzyos ...
Posted by Michael Wonder on 27 Apr 2023
First vaccine to protect older adults from respiratory syncytial virus (RSV) infection
26 April 2023 - EMA has recommended a marketing authorisation in the European Union for Arexvy (recombinant, adjuvanted), the first vaccine ...
Posted by Michael Wonder on 26 Apr 2023
Highlights from the 24-26 April 2023 CHMP meeting
26 April 2023 - The EMA’s CHMP recommended seven medicines for approval at its April 2023 meeting. ...
Posted by Michael Wonder on 26 Apr 2023
Akebia receives European Commission approval for Vafseo (vadadustat) for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
25 April 2023 - -- Akebia Therapeutics today announced that the European Commission has granted marketing authorisation for Vafseo (vadadustat), ...
Posted by Michael Wonder on 26 Apr 2023
Celltrion seeks approval for Xolair biosimilar in EU
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
Posted by Michael Wonder on 26 Apr 2023
European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
25 April 2023 - Regulatory submission based on pivotal data from Part 1 of the RUBY Phase 3 trial. ...
Posted by Michael Wonder on 24 Apr 2023
EMA publishes agenda for 24-26 April 2023 CHMP meeting
24 April 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted 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 ...