Is Tovorafenib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Tovorafenib, including OJEMDA (Prescription); OJEMDA (Prescription).

Is Tovorafenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tovorafenib: Ojemda.

Are there safety signals or safety updates for Tovorafenib?

US FDA: 2 entries (latest 2025-08-27).

Active substance

Tovorafenib

US FDA 2
EMA 1
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OJEMDA	100MG	tablet · oral	DAY ONE BIOPHARMS	Prescription	23 Apr 2024
OJEMDA	25MG/ML	for suspension · oral	DAY ONE BIOPHARMS	Prescription	23 Apr 2024

EMA European Union — centrally authorised medicines

Ojemda Ipsen Pharma · Authorised · authorised 20 Apr 2026 · ATC L01EC04

Therapeutic indication (EMA)

Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2)

Safety signals and safety-related labeling changes

US FDA 27 Aug 2025 OJEMDA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Aug 2025 OJEMDA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tovorafenib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.