US Regulator to Fast-Track Rare Disease Drug Approvals

US Health Secretary Robert F. Kennedy Jr. announced plans to fast-track approval for rare disease treatments, aiming to make the country the hub of biotechnology innovation. The move comes as other countries, including China, accelerate their drug development processes.

Kennedy made the comments during a meeting with industry executives, researchers, and FDA officials. Vinay Prasad, the top vaccine and biologics official at the FDA, vowed to rapidly make therapies available once they show promise of biomedical success.

The faster regulatory process is seen as crucial for rare disease treatments, which risk being overtaken by other countries if approval processes are too slow. Companies such as Sarepta, Dyne Therapeutics, and Lexeo Therapeutics have already shown increased share prices following the announcement.

Source: https://www.reuters.com/business/healthcare-pharmaceuticals