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In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...
Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...
Ultragenyx Pharmaceutical said federal regulators have issued a complete response letter to its application for a metabolic disorder treatment that may delay the potential approval to 2026.
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