Neurofibromatosis Type

Top drugs studied for this disease

All Approvals Safety alerts Label changes Trial results Research Guidance Withdrawals

EMA approval · 2026-08-13
EMA Authorised: Ezmekly (mirdametinib) — Merck Europe B.V.
EU authority authorised Ezmekly (mirdametinib) for Neurofibromatosis type 1 with neurofibromas, including plexiform neurofibroma, under cond…
EMA approval · 2026-07-01
EMA Authorised: Koselugo (selumetinib sulfate) — AstraZeneca AB
Koselugo (selumetinib sulfate) has been authorised by the EMA for Neurofibromatosis Type 1 under conditional approval as an orphan medicine.
EMA approval · 2026-04-21
EMA Authorised: Ezmekly (mirdametinib) — SpringWorks Therapeutics Ireland Limited
The European Medicines Agency authorised Ezmekly (mirdametinib) for neurofibromatosis type 1 with plexiform neurofibromas, under conditional…
EMA approval · 2026-01-28
EMA Authorised: Koselugo (selumetinib sulfate) — AstraZeneca AB
The EMA authorized Koselugo (selumetinib) for Neurofibromatosis type 1 with conditional approval and orphan medicine designation. This repre…
FDA approval · 2025-11-19
FDA Approved: KOSELUGO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for KOSELUGO (selumetinib) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2025-09-10
FDA Approved: KOSELUGO — Original Application (AstraZeneca Pharmaceuticals LP)
FDA approved KOSELUGO (selumetinib) as an original application for pediatric patients with neurofibromatosis type 1 and inoperable plexiform…
FDA approval · 2024-01-24
FDA Approved: KOSELUGO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for KOSELUGO (selumetinib) from AstraZeneca, resulting in updated labeling for the product.
FDA approval · 2021-12-22
FDA Approved: KOSELUGO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for KOSELUGO (selumetinib) from AstraZeneca Pharmaceuticals LP.
FDA approval · 2020-04-10
FDA Approved: KOSELUGO — Original Application (AstraZeneca Pharmaceuticals LP)
FDA approved KOSELUGO (selumetinib) through an Original Application for pediatric neurofibromatosis type 1 with inoperable plexiform neurofi…