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
Emphasizes the need for a collective effort on bolstering resilience across economies, societies, healthcare systems, education systems and infrastructure
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
Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain
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
Reports revenue growth of 9% to INR 882 crores in Q2 FY24
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
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