pdufa.bio

Susvimo (ranibizumab injection)

Updated ยทnext FDA decision on the calendar

Susvimo (ranibizumab injection) 2 FDA decisions on record below. Every date links its source.

RHHBY catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Feb 4, 2025 ✓ ApprovedRHHBYPDUFA · May 22, 2025 ✓ ApprovedRHHBY

Questions

When is Susvimo (ranibizumab injection)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Susvimo (ranibizumab injection); 2 FDA decisions are on record below.

What happened at Susvimo (ranibizumab injection)'s most recent FDA decision?

On May 22, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Susvimo (ranibizumab injection) been approved by the FDA?

Yes. The FDA approved an application for Susvimo (ranibizumab injection) on May 22, 2025; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.