FDAsafety guidance66% confidence
FDA AP — ROMVIMZA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Deciphera Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA219304. Sponsor: DECIPHERA PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: VIMSELTINIB.
Supporting Context
- Therapeutic area
- Oncology · Small Molecule
- Sub-indication
- General
Related signal: FDA Accepts Supplemental NDA for Romvimza (Vimselitinib) by Deciphera Pharmaceuticals