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BridgeBio Pharma Says FDA Has Granted Breakthrough Therapy Designation To Oral Infigratinib Under Development For Children With Achondroplasia

Benzinga ·  Sep 17 07:32

Breakthrough Therapy Designation is designed to expedite the development and regulatory review of drugs in the U.S. that meet stringent criteria.

Drugs qualifying for this Designation must show preliminary clinical evidence that the drug may demonstrate a substantial improvement on clinically significant endpoints over available therapies.

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