FDAapproval95% confidence
FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (ild) as Merck; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Cardiology · Hypercholesterolemia
- Sub-indication
- Ild
Related signal: Merck's LIPFENDRA Approved as First Oral PCSK9 Inhibitor for Hypercholesterolemia