These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector
Approval marks Venus Remedies’ first anti-infective marketing authorization in Indonesia and enables the country’s first generic entry for this critical antibiotic combination
This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo to patients in France, Denmark, Iceland, Sweden, Finland and Norway
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
Full approval will depend on verification of clinical benefit in a confirmatory trial
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
Hansoh Pharma will receive an upfront payment in the low double-digit millions
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