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.
The product will be manufactured at Lupin’s Nagpur facility in India
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
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
Expanded collaboration with Vanguard Renewables aims to significantly increase the productivity of US renewable natural gas generation
Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).
This product will be manufactured at Lupin’s Pithampur facility in India
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