Relapsing Forms of Multiple Sclerosis

• FDA approval · 2025-08-18
  FDA Approved: OCREVUS ZUNOVO — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for OCREVUS ZUNOVO (ocrelizumab and hyaluronidase) from Genentech, expanding administration options …

• FDA approval · 2024-06-10
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  FDA approved Genzyme Corporation's supplemental application for AUBAGIO (teriflunomide).

• FDA approval · 2024-06-05
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Mayzent (siponimod) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2024-06-05
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application to authorize a Zeposia 7-day starter pack (ozanimod hydrochloride) from Celgene Corporation.

• FDA approval · 2023-08-18
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Ocrevus (ocrelizumab) from Genentech, Inc. The action expands the drug's approved indication…

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• FDA approval · 2022-06-21
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA granted approval of a supplemental application for MAYZENT (siponimod) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-12-15
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application to introduce a 7-day starter pack of Zeposia (ozanimod hydrochloride) for Celgene Corporation.

• FDA approval · 2021-05-27
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application to add a 7-day starter pack for ZEPOSIA (ozanimod hydrochloride), expanding dosing packaging for the…

• FDA approval · 2020-04-28
  FDA Approved: BAFIERTAM — Original Application (Banner Life Sciences LLC)

  FDA approved BAFIERTAM (monomethyl fumarate) from Banner Life Sciences LLC via an original NDA (NDA210296) for relapsing forms of multiple s…

• FDA approval · 2019-03-26
  FDA Approved: MAYZENT — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approves Mayzent (siponimod) from Novartis Pharmaceuticals Corporation in an original NDA for the treatment of relapsing forms of multip…