FDA
Stories
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FDA classifies flushing and storage solution for vascular autografts at room temperature as class II
The FDA announced that it is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The order identifies the special controls that apply to the device type and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature.
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FDA approves first pediatric heart valve built to be expanded as a child grows
Edwards Lifesciences' Autus Size-Adjustable Valve is also the first valve approved in the U.S. with polymeric leaflets instead of animal tissue.
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FDA approves Emcitate, the first treatment for MCT8 deficiency
Egetis Therapeutics' tiratricol treats the excess blood thyroid hormone of Allan-Herndon-Dudley syndrome. The company also received a rare pediatric disease priority review voucher.
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FDA rewrites drug safety rules to say “nonclinical,” not “animal,” testing
A direct final rule takes effect February 4, 2027, unless the agency receives significant adverse comments by December 7, 2026.
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FDA approves Fayuvi, the first gene therapy for Sanfilippo syndrome type A
Ultragenyx's one-time AAV9 infusion received standard full approval for children with MPS IIIA, and the company received a priority review voucher.