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
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
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
This product will be manufactured at Lupin’s Pithampur facility in India
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
Revenue in the three months ended on Oct. 1 also slipped by 42% to US$ 13.23 billion
The companies plan to start a pivotal Phase 3 trial in the coming months
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