Cholangiocarcinoma

• EMA approval · 2026-03-17
  EMA Authorised: Pemazyre (pemigatinib) — Incyte Biosciences Distribution B.V.

  The European Medicines Agency authorised Pemazyre (pemigatinib) for cholangiocarcinoma with conditional approval and orphan medicine designa…

• CLINICAL_TRIALS approval · 2026-03-10
  Clinical Trial Update: Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

  Expanded Access study of TAS-120 (futibatinib) in patients with advanced cholangiocarcinoma harboring FGFR2 rearrangements, with the drug re…

• EMA approval · 2026-02-25
  EMA Authorised: Tibsovo (Ivosidenib) — Les Laboratoires Servier

  The European Medicines Agency authorised Tibsovo (ivosidenib) for acute myeloid leukemia and cholangiocarcinoma in the EU, with Les Laborato…

• EMA approval · 2025-10-29
  EMA Authorised: Lytgobi (Futibatinib) — Taiho Pharma Netherlands B.V.

  EU authorises Lytgobi (futibatinib) for cholangiocarcinoma with conditional approval.

• FDA approval · 2022-08-26
  FDA Approved: PEMAZYRE — Supplemental Application (Incyte Corporation)

  FDA approved a supplemental application for Pemazyre (pemigatinib) filed by Incyte Corporation, indicating an update to the drug's labeling …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-02-23
  FDA Approved: PEMAZYRE — Supplemental Application (Incyte Corporation)

  The FDA approved a supplemental application for Pemazyre (pemigatinib) from Incyte Corporation.

• FDA approval · 2020-04-17
  FDA Approved: PEMAZYRE — Original Application (Incyte Corporation)

  FDA approval of Pemazyre (pemigatinib) from Incyte as an original application for the treatment of cholangiocarcinoma.

• FDA approval ·
  FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

  FDA grants seventh approval under the National Priority Voucher Pilot Program for Bizengri (zenocutuzumab-zbco) to treat NRG1 fusion-positiv…