Drug Approval | November 21, 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Decision on EU marketing authorisation expected for momelotinib by early 2024
Decision on EU marketing authorisation expected for momelotinib by early 2024
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Phase 3 data expected in the second half of 2024
Yesafili, received marketing authorization approval from the European Commission for the European Union
Digitally enabled drug discovery for oncology with potential to accelerate the delivery of new cancer therapies to patients
General Medicine grows 5% and Vaccines 10% led by Shingrix
We are redesigning Bayer to focus only on what’s essential for our mission, ‘Health for all, hunger for none’”
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