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
Gene therapy AB-1005 being developed to locally increase glial cell line-derived neurotrophic factor (GDNF) levels
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
The countrywide initiative aims to spread awareness, educate the public & ensure that no one is left behind in the fight against respiratory diseases
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
Extraintestinal pathogenic E. coli (ExPEC) has been identified as the leading bacterial cause of sepsis
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
Phase 3 data expected in the second half of 2024
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