Progressive Familial Intrahepatic Cholestasis

• FDA approval · 2025-12-19
  FDA Approved: BYLVAY — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  FDA approved a supplemental application for BYLVAY (odevixibat) from Ipsen Biopharmaceuticals, Inc.

• EMA approval · 2025-07-11
  EMA Authorised: Bylvay (odevixibat) — Ipsen Pharma

  EMA authorised Bylvay (odevixibat) from Ipsen Pharma for intrahepatic cholestasis as an orphan medicine with accelerated assessment.

• FDA approval · 2025-03-20
  FDA Approved: BYLVAY — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  FDA approved a supplemental application for BYLVAY (odevixibat) from Ipsen Biopharmaceuticals, Inc.

• FDA approval · 2024-07-24
  FDA Approved: LIVMARLI — Supplemental Application (Mirum Pharmaceuticals Inc.)

  The FDA approved a supplemental application for LIVMARLI (maralixibat chloride) submitted by Mirum Pharmaceuticals.

• FDA approval · 2023-06-13
  FDA Approved: BYLVAY — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved a supplemental application for BYLVAY (odevixibat) submitted by Ipsen Biopharmaceuticals, Inc. The action updates the label…

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• FDA approval · 2023-03-13
  FDA Approved: LIVMARLI — Supplemental Application (Mirum Pharmaceuticals Inc.)

  The FDA approved a supplemental application for LIVMARLI (maralixibat chloride) submitted by Mirum Pharmaceuticals Inc. The approval updates…

• FDA approval · 2021-09-29
  FDA Approved: LIVMARLI — Original Application (Mirum Pharmaceuticals Inc.)

  The FDA granted original approval for LIVMARLI (maralixibat chloride) through Mirum Pharmaceuticals' original NDA.

• FDA approval · 2021-07-20
  FDA Approved: BYLVAY — Original Application (Ipsen Biopharmaceuticals, Inc.)

  FDA approved BYLVAY (odevixibat) from Ipsen Biopharmaceuticals as the original application for the treatment of progressive familial intrahe…