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pdufa.bio

bevacizumab

Updated ยทnext FDA decision on the calendar

bevacizumab is a Outlook Therapeutics, Inc. program in Neovascular Age-related Macular Degeneration. Its next catalyst is a Readout in Dec 2027. 4 FDA decisions on record below. Every date links its source.

OTLK catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

bevacizumab is marketed as LYTENAVA (bevacizumab-vikg); the events below include those tracked under the brand name. Indication under review: Neovascular Age-related Macular Degeneration. Sponsor: Outlook Therapeutics, Inc. (OTLK). Market-cap tier at the time we tracked it: Micro. We track 6 catalyst events for this program: 1 upcoming and 5 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 · Dec 31, 2025 CRLOTLKPDUFA · Mar 5, 2026 CRLOTLKPDUFA · Apr 7, 2026 CRLOTLKPDUFA · Jul 24, 2026 ✓ ApprovedOTLKPDUFA · Jul 29, 2026OTLKReadout · Dec 2027OTLK

Questions

When is bevacizumab's next FDA decision or readout?

The next tracked catalyst for bevacizumab is a Readout in Dec 2027.

What happened at bevacizumab's most recent FDA decision?

On Jul 24, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is bevacizumab used for?

In our records bevacizumab is under review or in development for Neovascular Age-related Macular Degeneration.

Who makes bevacizumab?

Outlook Therapeutics, Inc. (OTLK).

Has bevacizumab been approved by the FDA?

Yes. The FDA approved an application for bevacizumab on Jul 24, 2026; 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.