The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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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