FDAsafety guidance65% confidence
FDA AP — PHESGO (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Alembic Pharmaceuticals.
Regulatory Analysis
Application BLA761170. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF.
Supporting Context
- Therapeutic area
- Oncology · Tyrosine Kinase Inhibitor
- Sub-indication
- General
Related signal: Alembic submits ANDA for Bosutinib Monohydrate