PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
BUSINESS
FDA Rejects Capricor/Nippon Shinyaku’s DMD Cell Therapy, Seeking More Data
Capricor Therapeutics has hit a regulatory snag with its Duchenne muscular dystrophy (DMD) cell therapy, as the US FDA issued a complete response letter (CRL) saying the current application for deramiocel does not meet the agency’s bar for efficacy. Commercial…
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