Read more about the article FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases
FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases

FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases

The agency's new "Plausible Mechanism Framework" creates a first-of-its-kind regulatory pathway for genome editing and RNA-based therapies targeting small patient populations where traditional clinical trials are not feasible. The U.S.…

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Read more about the article Patient-Centric Trials in Advancing Cancer Research: A Journey of Progress & Hope
World Cancer Day - Patient-Centric Oncology Clinical Trials in Advancing Cancer Research - Lambda CRO

Patient-Centric Trials in Advancing Cancer Research: A Journey of Progress & Hope

On World Cancer Day, we recognize the importance of cancer research in expanding early access to investigational therapies and generating evidence that informs progress in oncology care. At Lambda Therapeutic…

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Read more about the article EMA and FDA Publish Common Principles for AI in Drug Development
EMA and FDA Publish Common Principles for AI in Drug Development - Lambda CRO

EMA and FDA Publish Common Principles for AI in Drug Development

Artificial intelligence is increasingly being applied across the medicine development lifecycle, including early research, clinical trials, manufacturing, and safety monitoring. As the use of AI expands, regulatory clarity has become…

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Read more about the article Clinical Research Update – February 2025
Clinical Research Updates Latest Newsletter February 2025

Clinical Research Update – February 2025

Clinical Research Updates provides key insights into the latest developments, trends, and breakthroughs shaping the clinical research landscape. Stay informed with concise summaries of regulatory updates, industry collaborations, and advancements…

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