Katy Spink Talks with Precision Medicine Online - 2026

March 2, 2026
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Can Rare Disease Drugmakers Trust FDA's Promises of Flexibility Amid String of Rejections?

Mar 02, 2026

By Jessica Kim Cohen

NEW YORK – While the US Food and Drug Administration touts new regulatory flexibility for rare disease drugs, recent rejections of regulatory applications are giving sponsors "whiplash" from mixed signals, biotech industry observers say.

Continue Reading Behind Paywall Here: https://www.precisionmedicineonline.com/regulatory-news-fda-approvals/can-rare-disease-drugmakers-trust-fdas-promises-flexibility-amid

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