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
OCEANIC-AF is one trial which evaluates asundexian versus apixaban in patients with atrial fibrillation at risk for stroke within the overall OCEANIC phase III program
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
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
Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain
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
Collaboration enables Brenntag to serve pharma customers in EMEA with chromatography silica gels
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
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