The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts
The new assets expand Biocon Biologics’ already robust oncology portfolio, which now includes 17 cancer therapies
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
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The approval is supported by data from three pivotal clinical trials
The decision secures legal protection in China for semaglutide, the blockbuster drug underpinning Novo Nordisk’s diabetes and obesity treatments
Experts warn that illegal products may be fake, contaminated, incorrectly dosed, or contain powerful unlisted ingredients
The company plans to use the newly secured funding to expand the indications of its Grabody platform into high-unmet-need areas
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
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