Gaucher Disease
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-25EMA Authorised: Vpriv (velaglucerase alfa) — Takeda Pharmaceuticals International AG Ireland Branch
The EMA authorises Vpriv (velaglucerase alfa) for Gaucher disease under accelerated assessment.
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EMA approval · 2026-07-27EMA Authorised: Cerdelga (Eliglustat (tartrate)) — Sanofi B.V.
Cerdelga (Eliglustat tartrate) has been authorised by EMA for Gaucher disease.
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EMA approval · 2026-07-09EMA Authorised: Zavesca (miglustat) — Advanz Pharma Limited
Authorization granted for Zavesca (miglustat) to Advanz Pharma Limited for Gaucher disease and Niemann-Pick diseases in the EU.
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EMA approval · 2026-01-28EMA Authorised: Zavesca (miglustat) — Janssen Cilag International NV
EMA authorised Zavesca (miglustat) for Gaucher disease and Niemann-Pick diseases; Janssen Cilag International NV is the marketing authorisat…
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EMA approval · 2026-01-28EMA Authorised: Vpriv (velaglucerase alfa) — Takeda Pharmaceuticals International AG Ireland Branch
The EMA authorised Vpriv (velaglucerase alfa) for Gaucher disease, with accelerated assessment.
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FDA approval · 2026-01-12FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)
FDA approved a supplemental application for Cerezyme (imiglucerase) from Genzyme Corporation, resulting in an updated labeling for the produ…
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EMA approval · 2025-12-19EMA Authorised: Yargesa (miglustat) — Piramal Critical Care B.V.
The European Medicines Agency authorised Yargesa (miglustat) for Gaucher disease, with Piramal Critical Care B.V. as the marketing authorisa…
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EMA approval · 2025-12-01EMA Authorised: Cerezyme (imiglucerase) — Sanofi B.V.
EMA authorised Cerezyme (imiglucerase) for Gaucher disease, with Sanofi B.V. listed as the marketing authorization holder.
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EMA approval · 2025-06-25EMA Authorised: Miglustat Dipharma (miglustat) — Dipharma Arzneimittel GmbH
The EMA authorised Miglustat Dipharma (miglustat) by Dipharma Arzneimittel GmbH for Gaucher disease, granting a European marketing authoriza…
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EMA approval · 2025-06-24EMA Authorised: Miglustat Gen.Orph (miglustat) — Gen.Orph
The EMA authorised Miglustat Gen.Orph for the treatment of Gaucher disease, marking a new regulatory approval for this product in the EU.
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EMA approval · 2025-05-16EMA Authorised: Cerdelga (Eliglustat (tartrate)) — Sanofi B.V.
The European Medicines Agency authorised Cerdelga (eliglustat tartrate) for Gaucher disease, with orphan medicine designation; decision date…
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FDA approval · 2024-12-19FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)
The FDA approved a supplemental application for Cerezyme (imiglucerase) submitted by Genzyme Corporation.
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FDA approval · 2024-07-10FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Elelyso (taliglucerase alfa) filed by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2024-07-10FDA Approved: VPRIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for VPRIV (velaglucerase alfa) by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2023-05-09FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for ELELYSO (taliglucerase alfa) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2022-08-30FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for ELELYSO (taliglucerase alfa) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2021-12-22FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)
The FDA approved a supplemental application for Cerezyme (imiglucerase) submitted by Genzyme Corporation. The action updates the product's a…
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FDA approval · 2020-12-10FDA Approved: VPRIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for VPRIV (velaglucerase alfa) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2020-11-03FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Elelyso (taliglucerase alfa) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2019-11-06FDA Approved: VPRIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for VPRIV (velaglucerase alfa) submitted by Takeda Pharmaceuticals America, Inc., authorizing re…
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FDA approval · 2019-10-21FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for ELELYSO (taliglucerase alfa) submitted by Pfizer Laboratories Div Pfizer Inc, under BLA022458.
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FDA approval · 2019-07-30FDA Approved: VPRIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for VPRIV (velaglucerase alfa) submitted by Takeda Pharmaceuticals America, Inc. This action updates…
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FDA approval · 2016-07-22FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)
FDA approved a supplemental Biologics License Application for Cerezyme (imiglucerase) by Genzyme Corporation.
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FDA approval · 2016-07-07FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)
FDA approved a supplemental application for Cerezyme (imiglucerase) submitted by Genzyme Corporation.
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FDA approval · 2016-06-15FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Elelyso (taliglucerase alfa) from Pfizer Laboratories Div Pfizer Inc, indicating an approved mod…