JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...
JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
GEN

uniQure Staggers as FDA Questions Data for Huntington’s Gene Therapy Candidate

uniQure has acknowledged that what it called “game changing” data in September showing significant slowing of Huntington’s disease (HD) progression in patients treated with its gene therapy candidate ...