Amyotrophic Lateral Sclerosis
📧 Sign up to get email alerts when something new happens for Amyotrophic Lateral Sclerosis.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2026-08-11FDA Approved: RILUZOLE — Supplemental Application (IMPAX LABS)
FDA supplemental application for riluzole by Impax Labs; indicates a supplemental approval process for riluzole's authorization.
-
FDA approval · 2025-09-11FDA Approved: TIGLUTIK — Supplemental Application (EDW PHARMA, INC)
FDA approved a supplemental application for TIGLUTIK (riluzole) filed by EDW PHARMA, INC, resulting in approved labeling changes.
-
EMA approval · 2025-05-15EMA Authorised: Riluzole Zentiva (riluzole) — Zentiva k.s.
The European Medicines Agency authorised Riluzole Zentiva (riluzole) by Zentiva k.s. for Amyotrophic Lateral Sclerosis on 15 May 2025.
-
FDA approval · 2024-12-23FDA Approved: EDARAVONE — Original Application (Sandoz Inc)
FDA approved a generic edaravone product from Sandoz Inc under an original application for the treatment of amyotrophic lateral sclerosis.
-
FDA approval · 2024-10-31FDA Approved: EDARAVONE — Original Application (XGen Pharmaceuticals DJB, Inc.)
The FDA approved the Original Application for edaravone from XGen Pharmaceuticals DJB, Inc., enabling a generic version of the ALS therapy t…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
EMA approval · 2024-08-21EMA Authorised: Rilutek (riluzole) — Sanofi Winthrop Industrie
EMA authorised Rilutek (riluzole) for use in amyotrophic lateral sclerosis, with Sanofi Winthrop Industrie as the marketing authorisation ho…
-
EMA approval · 2024-07-09EMA Authorised: Qalsody (tofersen) — Biogen Netherlands B.V.
The European Medicines Agency authorised Qalsody (tofersen) for amyotrophic lateral sclerosis, with orphan medicine designation.
-
CLINICAL_TRIALS approval · 2024-06-10Clinical Trial Update: Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral Sclerosis
The document indicates that an expanded access program for tofersen in people with SOD1-ALS has been approved for marketing, enabling broade…
-
FDA approval · 2024-05-06FDA Approved: EDARAVONE — Original Application (Gland Pharma Limited)
FDA approved the original ANDA for edaravone submitted by Gland Pharma Limited, establishing a generic version of the ALS treatment. This ap…
-
FDA approval · 2023-10-17FDA Approved: RILUZOLE — Supplemental Application (Florida Pharmaceutical Products, LLC)
FDA approved a supplemental application for riluzole by Florida Pharmaceutical Products, LLC, confirming approval status for a generic riluz…
-
FDA approval · 2023-04-25FDA Approved: QALSODY — Original Application (Biogen Inc.)
FDA approved QALSODY (tofersen) from Biogen in an original NDA (NDA215887). It is indicated for the treatment of amyotrophic lateral scleros…
-
FDA approval · 2022-08-02FDA Approved: RILUZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for riluzole submitted by Glenmark Pharmaceuticals Inc., USA.
-
FDA approval · 2022-05-12FDA Approved: RADICAVA ORS — Original Application (Shionogi Inc.)
The FDA approved RADICAVA ORS (edaravone) for use as an oral suspension under an Original Application by Shionogi Inc., adding an oral formu…
-
FDA approval · 2021-08-13FDA Approved: RILUZOLE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for riluzole submitted by Ascend Laboratories, LLC, updating the approved riluzole product.
-
FDA approval · 2021-03-15FDA Approved: RADICAVA — Supplemental Application (Shionogi Inc.)
The FDA approved a supplemental application for RADICAVA (edaravone) from Shionogi Inc., marking an additional regulatory approval for the p…
-
FDA approval · 2020-09-09FDA Approved: RILUZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical's supplemental application for riluzole, authorizing the marketing of a generic riluzole product in the Unit…
-
FDA approval · 2019-12-13FDA Approved: TIGLUTIK — Supplemental Application (EDW PHARMA, INC)
The FDA approved a supplemental application for TIGLUTIK (riluzole) submitted by EDW Pharma, Inc.
-
FDA approval · 2019-12-09FDA Approved: RILUZOLE — Original Application (Florida Pharmaceutical Products, LLC)
The FDA approved an original Abbreviated New Drug Application for riluzole from Florida Pharmaceutical Products, LLC, establishing a generic…
-
FDA approval · 2019-11-01FDA Approved: RADICAVA — Supplemental Application (Shionogi Inc.)
The FDA approved a supplemental application for RADICAVA (edaravone) submitted by Shionogi Inc.
-
FDA approval · 2018-11-15FDA Approved: RADICAVA — Supplemental Application (Shionogi Inc.)
The FDA approved a supplemental application for RADICAVA (edaravone) submitted by Shionogi Inc. The action expands the regulatory approval a…
-
FDA approval · 2018-09-05FDA Approved: TIGLUTIK — Original Application (EDW PHARMA, INC)
FDA approved Tiglutik (riluzole) under an Original Application from Edw Pharma, Inc., adding a riluzole product to treat amyotrophic lateral…
-
FDA approval · 2018-08-17FDA Approved: RADICAVA — Supplemental Application (Shionogi Inc.)
The FDA approved a supplemental NDA for RADICAVA (edaravone) from Shionogi Inc., updating its regulatory status after the supplemental appli…
-
FDA approval · 2017-05-05FDA Approved: RADICAVA — Original Application (Shionogi Inc.)
FDA approved the original application for RADICAVA (edaravone) by Shionogi Inc. for the treatment of amyotrophic lateral sclerosis.
-
FDA approval · 2016-03-30FDA Approved: RILUZOLE — Original Application (Ascend Laboratories, LLC)
FDA approved the original application for riluzole by Ascend Laboratories, LLC.
-
FDA approval · 2013-06-18FDA Approved: RILUZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved the original application for riluzole (generic riluzole) from Glenmark Pharmaceuticals, marking approval of a generic riluzole …