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Clinical Research

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FDA Panel Rejects Deramiocel Cardiac Claim After Lancet Publishes HOPE‑3 Results

A 9–3 advisory vote and critical FDA reviews increase doubt about final approval ahead of the August 22 PDUFA date.

FDA Grants Orphan Drug Status to Immutep’s Efti for Soft Tissue Sarcoma

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

Sorfequiline Outperforms Standard TB Regimens in Phase 2 Trial

Datroway Extends Survival Over Chemotherapy in First-Line TNBC Ineligible for Immunotherapy