The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio
India's pharmaceutical sector is rapidly shifting from a generics-led foundation to an innovation-driven ecosystem
The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
Renalyx will continue operating as an independent unit within the group
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses
CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents
The trial tested six injectable doses and three oral doses over as long as 36 weeks
The trials, designed to assess whether semaglutide could slow cognitive decline, showed no significant difference compared to placebo in the progression of Alzheimer’s disease over two years
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