Lambert-eaton Myasthenic Syndrome

• CLINICAL_TRIALS approval · 2025-03-26
  Clinical Trial Update: Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome

  Amifampridine phosphate has received marketing approval for Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndrome. This updat…

• EMA approval · 2024-12-18
  EMA Authorised: Firdapse (previously Zenas) (amifampridine) — SERB SA

  The European Medicines Agency authorised Firdapse (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome. The marketing auth…

• FDA approval · 2024-05-30
  FDA Approved: FIRDAPSE — Supplemental Application (Catalyst Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for FIRDAPSE (amifampridine phosphate) from Catalyst Pharmaceuticals. The approval indicates a m…

• FDA approval · 2023-05-15
  FDA Approved: FIRDAPSE — Supplemental Application (Catalyst Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for FIRDAPSE (amifampridine phosphate) submitted by Catalyst Pharmaceuticals, Inc. The approval …

• EMA approval · 2022-05-24
  EMA Authorised: Amifampridine SERB (amifampridine phosphate) — SERB SA

  European Medicines Agency authorises amifampridine phosphate (SERB) for various neuromuscular and autoimmune conditions, with Lambert-Eaton …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-03-01
  FDA Approved: FIRDAPSE — Supplemental Application (Catalyst Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for FIRDAPSE (amifampridine phosphate) from Catalyst Pharmaceuticals. The action modifies the re…

• FDA approval · 2018-11-28
  FDA Approved: FIRDAPSE — Original Application (Catalyst Pharmaceuticals, Inc.)

  FDA approved FIRDAPSE (amifampridine phosphate) in this original application for Lambert-Eaton myasthenic syndrome, marking the drug's initi…