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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.

Genentech Licenses SanegeneBio RNAi Program in Deal Worth Up to $1.7 Billion

FDA Grants Orphan Drug Status to Cellenkos’ CK0804 for Myelofibrosis

FDA Approves First Eye Implant to Preserve Vision in Rare Macular Telangiectasia