This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The approval is backed by data showing deep, durable responses and manageable tolerability
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
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Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
The approval introduces a needle-free alternative to injectable GLP-1 therapies
India’s pharmaceutical sector stands at a pivotal inflection point
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