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DATA GRAPHICS | Data Byte

15 PDUFA dates on FDA’s roster in June

Upcoming decisions include HER3 ADC from Daiichi-Merck and full approval for Sarepta’s DMD gene therapy 

By Gunjan Ohri, Data Content Analyst
June 5, 2024 11:38 PM UTC

FDA is due to make decisions this month on at least six new medicines and nine label expansions. Highlights include the first HER3-targeted antibody-drug conjugate and Sarepta’s DMD gene therapy.

An approval of patritumab deruxtecan from partners Merck & Co. Inc. (NYSE:MRK) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) would make the product first-in-class against HER3...

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