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
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
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
The product will be manufactured at Lupin’s Nagpur facility in India
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
Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain
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