Requests that the FDA further and more deeply and critically investigate the trial conduct of the ORATORIO trial (the sole pivotal trial of ocrelizumab/Ocrevus for PPMS) in light of the FDAs request to withdraw their previous approval of Tavneos | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4732

Requests that the FDA further and more deeply and critically investigate the trial conduct of the ORATORIO trial (the sole pivotal trial of ocrelizumab/Ocrevus for PPMS) in light of the FDAs request to withdraw their previous approval of Tavneos

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMay 1, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Ocrevus - Part 1 to Part 6	May 1, 2026	--

Keywords

CDER

Citizen Petition

Request that the FDA further and more deeply and

critically investigate the trial conduct of the

ORATORIO trial (the sole pivotal trial of

ocrelizumab/Ocrevus for PPMS) in light of the

FDA's request to withdraw their

previous approval of Tavneos

Data from Regulations.gov