Duchenne Muscular Dystrophy
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-07-03EMA Authorised: Duvyzat (givinostat hydrochloride monohydrate) — Italfarmaco S.p.A.
EMA authorised Duvyzat (givinostat hydrochloride monohydrate) for Duchenne muscular dystrophy under conditional and orphan designation.
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EMA approval · 2026-04-08EMA Authorised: Agamree (vamorolone) — Santhera Pharmaceuticals (Deutschland) GmbH
The European Medicines Agency authorised Agamree (vamorolone) by Santhera Pharmaceuticals for Duchenne muscular dystrophy, with orphan medic…
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EMA approval · 2026-03-27EMA Authorised: Duvyzat (givinostat hydrochloride monohydrate) — Italfarmaco S.p.A.
The European Medicines Agency authorised Duvyzat, containing givinostat hydrochloride monohydrate, for Duchenne muscular dystrophy under a c…
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FDA approval · 2026-01-27FDA Approved: DEFLAZACORT ORAL SUSPENSION — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a generic deflazacort oral suspension from Sun Pharmaceutical Industries under ANDA 219930.
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FDA approval · 2026-01-13FDA Approved: DEFLAZACORT ORAL SUSPENSION — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
The FDA approved a supplemental application to add an oral suspension formulation of deflazacort, expanding the available dosage form for Zy…
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FDA approval · 2026-01-06FDA Approved: AMONDYS 45 — Supplemental Application (Sarepta Therapeutics, Inc.)
FDA approved a supplemental application for Amondys 45 (casimersen) from Sarepta Therapeutics, Inc.
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FDA approval · 2025-12-12FDA Approved: DEFLAZACORT — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic version of deflazacort.
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EMA approval · 2025-04-25New treatment against Duchenne muscular dystrophy
The European Medicines Agency announced the approval of Duvyzat as a new treatment for Duchenne muscular dystrophy, for patients aged six an…
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FDA approval · 2024-12-27FDA Approved: EXONDYS 51 — Supplemental Application (Sarepta Therapeutics, Inc.)
The FDA approved a supplemental application for Exondys 51 (eteplirsen) from Sarepta Therapeutics.
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FDA approval · 2024-11-05FDA Approved: DEFLAZACORT — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved the original Abbreviated New Drug Application for Deflazacort from Upsher-Smith Laboratories, granting a generic version of def…
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FDA approval · 2024-10-29FDA Approved: DEFLAZACORT ORAL SUSPENSION — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for Deflazacort oral suspension by Cranbury Pharmaceuticals, expanding the availability of defla…
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FDA approval · 2024-07-11FDA Approved: AMONDYS 45 — Supplemental Application (Sarepta Therapeutics, Inc.)
FDA approved a supplemental application for Amondys 45 (casimersen) from Sarepta Therapeutics, Inc., related to Duchenne muscular dystrophy.
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FDA approval · 2024-06-05FDA Approved: AGAMREE — Supplemental Application (Catalyst Pharmaceuticals, Inc.)
FDA approved a supplemental application for AGAMREE (vamorolone) submitted by Catalyst Pharmaceuticals, Inc.
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FDA approval · 2024-06-05FDA Approved: EMFLAZA — Supplemental Application (PTC Therapeutics, Inc.)
The FDA approved a supplemental application for EMFLAZA (deflazacort) by PTC Therapeutics, Inc. This action updates the drug’s regulatory st…
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FDA approval · 2024-06-04FDA Approved: VYONDYS 53 — Supplemental Application (Sarepta Therapeutics, Inc.)
The FDA approved a supplemental application for VYONDYS 53 (golodirsen) filed by Sarepta Therapeutics, expanding regulatory status for Duche…
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FDA approval · 2024-04-25FDA Approved: DEFLAZACORT ORAL SUSPENSION — Original Application (Cranbury Pharmaceuticals, LLC)
FDA approved Deflazacort Oral Suspension from Cranbury Pharmaceuticals as an Original Application (ANDA), providing a generic version of def…
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FDA approval · 2024-02-09FDA Approved: DEFLAZACORT — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for deflazacort from Aurobindo Pharma Limited, enabling a generic version of deflazacort to be marketed in th…
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FDA approval · 2023-10-26FDA Approved: AGAMREE — Original Application (Catalyst Pharmaceuticals, Inc.)
FDA approved AGAMREE (vamorolone) from Catalyst Pharmaceuticals in an original NDA for Duchenne muscular dystrophy.
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FDA approval · 2023-03-23FDA Approved: AMONDYS 45 — Supplemental Application (Sarepta Therapeutics, Inc.)
FDA approved a supplemental application for Amondys 45 (casimersen) from Sarepta Therapeutics, Inc.
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FDA approval · 2022-01-18FDA Approved: EXONDYS 51 — Supplemental Application (Sarepta Therapeutics, Inc.)
The FDA approved a supplemental application for Exondys 51 (eteplirsen) submitted by Sarepta Therapeutics, expanding its regulatory status.
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FDA approval · 2021-03-11FDA Approved: VILTEPSO — Supplemental Application (NS Pharma, Inc.)
The FDA approved a supplemental application for VILTEPSO (viltolarsen) from NS Pharma, Inc., resulting in updated labeling for Duchenne musc…
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FDA approval · 2021-02-25FDA Approved: AMONDYS 45 — Original Application (Sarepta Therapeutics, Inc.)
FDA approves AMONDYS 45 (casimersen) via an original application for Duchenne muscular dystrophy.
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FDA approval · 2021-02-11FDA Approved: VYONDYS 53 — Supplemental Application (Sarepta Therapeutics, Inc.)
FDA approved a supplemental application for VYONDYS 53 (golodirsen) from Sarepta Therapeutics, Inc. The approval pertains to Duchenne muscul…
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FDA approval · 2020-08-12FDA Approved: VILTEPSO — Original Application (NS Pharma, Inc.)
The FDA approved Viltepso (viltolarsen) from NS Pharma, Inc. under Original NDA212154 for Duchenne muscular dystrophy amenable to exon 53 sk…
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FDA approval · 2020-07-10FDA Approved: EMFLAZA — Supplemental Application (PTC Therapeutics, Inc.)
The FDA approved a supplemental application for EMFLAZA (deflazacort) submitted by PTC Therapeutics, Inc.