FDAapproval95% confidence
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (ophthalmology) as Mankind Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Ophthalmology · Glaucoma
- Sub-indication
- Ophthalmology
Related signal: FDA Approves Brimonidine Tartrate Application ANDA220398 by Mankind Pharma