Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
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
Leading the showcase is FCT iStream, Fujifilm’s latest CT scanner built on a “Less is More” design philosophy
Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
The Phase III programme, Enith1 and Enith2, is expected to launch this quarter
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