Tecentriq SC reduces treatment administration time by nearly 80 percent and has the potential to lower indirect treatment costs
The approval was driven by data from the Phase III TULIP-SC trial
CDSCO-approved therapy enters India’s fast-growing post-patent GLP-1 market with fully integrated API, formulation and pen manufacturing
The trial also demonstrated significant improvements across multiple secondary endpoints
The company now offers the complete range of Apomorphine Hydrochloride in different fill volumes
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
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
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
HYMPAVZI’s safety profile was generally favorable
While Merck can appeal, Halozyme said it expects the order to hold
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