Santhera

Santhera Announces Approval in Canada for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy

Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD in Canada. 3 October 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals today notes that Health Canada has approved AGAMREE (vamorolone) for the treatment of Duchenne...

Santhera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS Scotland

AGAMREE® is approved by MHRA for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in UK 14 January 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals announces that the Scottish Medicines Consortium (SMC) has published recommendations that AGAMREE® (vamorolone) is accepted for use within NHS Scotland for the treatment of Duchenne...

Santhera Enters into Supply and Distribution Agreement for AGAMREE (Vamorolone) with Clinigen Group

6 January 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals announces the signing of an exclusive agreement with Clinigen Group to manage the supply and distribution of AGAMREE (vamorolone) in countries where the product is not otherwise commercially available. Santhera Pharmaceuticals and Clinigen Group announce that they have signed a Supply and Distribution Agreement for AGAMREE...

Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy

China’s National Medical Products Administration (NMPA) approved AGAMREE® for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved DMD therapy in China. 11 December 2024 -- Pratteln, Switzerland -- Santhera Pharmaceuticals announces that China’s National Medical Products Administration (NMPA) has approved AGAMREE®...

Santhera Receives Positive Recommendation from NICE for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy

AGAMREE® has been recommended by NICE for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in England, Wales and Northern Ireland Santhera will be working closely with NHS England, NHS Wales and NHS Northern Ireland to ensure rapid patient access Santhera also pursuing reimbursement via the Scottish Medicines Consortium (SMC)...

Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy

Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023 - Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD) for filing. The FDA has set October 26, 2023, as the...
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