FDAapproval54% confidence
Prescription Drug User Fee Amendments
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (dme) as Merck.
Regulatory Analysis
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
Supporting Context
- Therapeutic area
- Oncology · Diffuse Large B-Cell Lymphoma
- Sub-indication
- DME
Related signal: Zilovertamab Vedotin Shows Promise in rrDLBCL with Standard Care in Phase 2/3 Study