pdufa.bio

bevacizumab

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

bevacizumab is an 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. FDA approval tracked on pdufa.bio: neovascular Age-related Macular Degeneration (approved Jul 24, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Outlook Therapeutics, Inc. (OTLK). Market-cap tier at the time we tracked it: Micro. We track 5 catalyst events for this program: 1 upcoming and 4 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

FDA decision · Dec 31, 2025 CRLOTLKFDA decision · Mar 5, 2026 CRLOTLKFDA decision · Apr 7, 2026 CRLOTLKFDA decision · Jul 24, 2026 ✓ ApprovedOTLKReadout · Dec 2027OTLK

Specialist biotech funds holding OTLK, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Perceptive Advisors3,139,216$5.0 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

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 FDA-approved for neovascular Age-related Macular Degeneration (approved Jul 24, 2026). Other approved uses may not be tracked here; the FDA label is the full record.

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.