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
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
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
Digitally enabled drug discovery for oncology with potential to accelerate the delivery of new cancer therapies to patients
Lack of technology transfer stands out as a formidable barrier
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