Clesrovimab PDUFA date: FDA decision expected March 22, 2027
The FDA is expected to decide on Clesrovimab from MERCK in Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease through their second RSV season by the PDUFA target action date of March 22, 2027. For Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease through their second RSV season. sNDA filing. Extracted from SEC filing: EXHIBIT 99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 29, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Clesrovimab?
- The FDA's PDUFA target action date for Clesrovimab is March 22, 2027. The FDA can act before that date, and the review can be extended.
- What is Clesrovimab being reviewed for?
- The application under FDA review covers Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease through their second RSV season.
- Which company is developing Clesrovimab?
- MERCK (MRK).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).