Multiple Sclerosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-11FDA Approved: GLATIRAMER ACETATE — Original Application (AJENAT PHARMACEUTICALS LLC)
The FDA approved an original application for a generic glatiramer acetate product by AJENAT Pharmaceuticals LLC, enabling a generic treatmen…
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EMA approval · 2026-02-03EMA Authorised: Gilenya (fingolimod hydrochloride) — Novartis Europharm Limited
The European Medicines Agency authorised Gilenya (fingolimod hydrochloride) for the treatment of multiple sclerosis, with Novartis Europharm…
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FDA approval · 2026-02-02FDA Approved: TYRUKO — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for TYRUKO (natalizumab-sztn) from Sandoz Inc, updating the regulatory file for this biosimilar unde…
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FDA approval · 2026-01-16FDA Approved: FINGOLIMOD — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for Fingolimod submitted by Glenmark Pharmaceuticals Inc., USA.
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EMA approval · 2026-01-13EMA Authorised: Mavenclad (cladribine) — Merck Europe B.V.
The EMA authorised Mavenclad (cladribine) from Merck Europe B.V. for multiple sclerosis, marking regulatory approval in the European Union.
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EMA approval · 2026-01-09EMA Authorised: Tysabri (natalizumab) — Biogen Netherlands B.V.
The European Medicines Agency authorised the marketing of Tysabri (natalizumab) by Biogen Netherlands B.V. for the treatment of Multiple Scl…
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FDA approval · 2025-12-31FDA Approved: GLATIRAMER ACETATE — Original Application (UPSHER-SMITH LABORATORIES, LLC)
FDA approved the original application for glatiramer acetate injection from Upsher-Smith Laboratories, establishing a generic version of the…
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FDA approval · 2025-12-16FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental abbreviated new drug application for tizanidine hydrochloride (generic tizanidine).
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EMA approval · 2025-12-11EMA Authorised: Teriflunomide Viatris (previously Teriflunomide Mylan) (teriflunomide) — Viatris Limited
The EMA authorised Teriflunomide Viatris for treatment of relapsing-relapsing multiple sclerosis, with Viatris Limited as the marketing auth…
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EMA approval · 2025-12-09EMA Authorised: Aubagio (teriflunomide) — Sanofi Winthrop Industrie
The EMA authorised Aubagio (teriflunomide) for multiple sclerosis, with Sanofi Winthrop Industrie listed as the marketing authorisation hold…
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EMA approval · 2025-11-28EMA Authorised: Fingolimod Mylan (Fingolimod) — Mylan Pharmaceuticals Limited
The European Medicines Agency authorised Fingolimod Mylan, a generic version of fingolimod, for relapsing-remitting multiple sclerosis.
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FDA approval · 2025-11-21FDA Approved: BACLOFEN — Supplemental Application (Medcore LLC)
FDA approved Medcore LLC's supplemental application for Baclofen (ANDA 214099).
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FDA approval · 2025-11-21FDA Approved: DALFAMPRIDINE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories, LLC's supplemental application for dalfampridine (generic) under ANDA206765.
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FDA approval · 2025-10-30FDA Approved: TYRUKO — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for TYRUKO (natalizumab-sztn) from Sandoz Inc. TYRUKO is a biosimilar to natalizumab (Tysabri) i…
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EMA approval · 2025-10-27EMA Authorised: Lemtrada (alemtuzumab) — Sanofi Belgium
The EMA has authorised Lemtrada (alemtuzumab) for the treatment of multiple sclerosis, with a decision date of 27 October 2025.
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EMA approval · 2025-10-16EMA Authorised: Avonex (interferon beta-1a) — Biogen Netherlands B.V.
EMA authorised Avonex (interferon beta-1a) for multiple sclerosis. The marketing authorisation holder is Biogen Netherlands B.V., with a dec…
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EMA approval · 2025-10-08EMA Authorised: Briumvi (ublituximab) — Neuraxpharm Pharmaceuticals S.L.
The European Medicines Agency authorised Briumvi (ublituximab) for multiple sclerosis, including relapsing-remitting disease, with Neuraxpha…
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EMA approval · 2025-08-26EMA Authorised: Dimethyl fumarate Accord (dimethyl fumarate) — Accord Healthcare Ltd
The EMA authorised a Dimethyl fumarate product from Accord Healthcare Ltd for the treatment of multiple sclerosis.
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FDA approval · 2025-08-22FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for GILENYA (fingolimod HCl) from Novartis Pharmaceuticals Corporation. The decision constitutes…
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EMA approval · 2025-08-21EMA Authorised: Fampyra (Fampridine) — Merz Therapeutics GmbH
The EMA authorised Fampyra (fampridine) by Merz Therapeutics GmbH for multiple sclerosis, confirming its use to improve walking in patients …
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FDA approval · 2025-08-21FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for MAYZENT (siponimod) to expand its indication to include treatment of secondary progressive multi…
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FDA approval · 2025-08-18FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Kesimpta (ofatumumab) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2025-08-18FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for OCREVUS (ocrelizumab) submitted by Genentech, Inc., indicating an update to the product labeling…
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FDA approval · 2025-08-12FDA Approved: TIZANIDINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for tizanidine from Zydus Lifesciences Limited (ANDA208187).
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FDA approval · 2025-08-06FDA Approved: TERIFLUNOMIDE — Supplemental Application (MSN LABORATORIES PRIVATE LIMITED)
FDA approved a supplemental application for teriflunomide from MSN Laboratories Private Limited.