The FDA has awarded Fast Track Designation to CUSP06, an innovative Cadherin-6 targeting Antibody-Drug Conjugate developed by OnCusp Therapeutics for platinum-resistant ovarian cancer treatment.
The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
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