Regulatory Approvals

The decision positions LANGLARA as only the fourth insulin glargine product available in the US market, joining established products commercialized by Novo Nordisk, Sanofi and Eli Lilly.

The tablet combines 100 mg of doravirine and 0.25 mg of islatravir in a once-daily formulation.

The Rembra platform extends the use of computed tomography beyond traditional diagnostic radiology into radiation therapy planning.

The approval grants the pharmaceutical giant the right to market Enflonsia across all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

The Verida system represents a leap forward in CT imaging, incorporating Philips’ third-generation Nano-panel Precise dual-layer detector alongside an AI-driven deep learning reconstruction engine.

The European Medicines Agency rejected Elevidys for ambulatory patients last year, citing insufficient evidence of effectiveness.

The approval specifically applies to adults diagnosed with obesity and does not extend to individuals who are overweight with a BMI below 30kg/m² using Wegovy for weight management.

The medication works as an add-on therapy alongside intranasal corticosteroids for patients whose condition fails to respond adequately to systemic corticosteroids or surgical intervention.

The ML3 designation emerged from a thorough WHO benchmarking process using the Global Benchmarking Tool, which evaluates the maturity and performance of national regulatory systems.

When combined with a reduced-calorie diet and regular physical activity, Foundayo helps patients shed excess weight and maintain their progress.