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Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.
Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
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The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027
Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy
In Dec 2018, Sandoz partnered with…
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The United States has about 38.4 million people living with diabetes, representing 11.6% of the total population. With growing prevalence, there is a significant unmet need for affordable diabetes medications.
Biocon Biologics recently announced the FDA approval of Kirsty, the first and only interchangeable biosimilar to NovoLog (Insulin Aspart).
Joshua Salsi, the Head of…

