Tag: FDA approval
Eli Lilly’s Obesity Drug Access: What We Know About FDA Approval Pathways
Regulatory pathways and corporate strategy shape early access to obesity drug candidates. Pharmaceutical acquisitions in the metabolic disease sector reflect…
FDA-Cleared AI Tool EchoNext Enables ECG-Based Heart Disease Screening
Pathway Labs' EchoNext, an FDA-cleared artificial intelligence tool, enables detection of structural heart disease using standard electrocardiogram data. Integration into…
FDA Approves Bemotrizinol: First New Sunscreen Ingredient in 25 Years
The FDA has approved bemotrizinol, the first new sunscreen active ingredient in 25 years, following decades of safe use across…
FDA Approves Sanofi’s Teplizumab for Children with Stage 3 Type 1 Diabetes
FDA approves Sanofi's teplizumab for children with stage 3 type 1 diabetes, expanding immunotherapy options for pediatric patients after previous…
FDA Approves First Treatment for Chronic Hepatitis Delta Virus Infection
The FDA has approved Hepcludex as the first treatment for chronic hepatitis delta virus infection in adults without advanced cirrhosis.…
Utah’s AI Sandbox Demonstrates Independent Oversight Model for Clinical AI
Utah's clinical AI sandbox has evaluated 47 AI tools across 12 healthcare systems while reducing testing timelines from 18 to…