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Duchenne News Tags: Santhera

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Antisense Therapeutics Astellas Pharma Avidity Biosciences Catalyst Pharmaceuticals Dyne Therapeutics Edgewise Therapeutics Entrada Therapeutics FibroGen Italfarmaco NS Pharma PepGen Pliant Therapeutics PTC Therapeutics REGENXBIO Santhera Sarepta Therapeutics Solid Biosciences Wave Life Sciences
June 20, 2023

Santhera Grants Exclusive North America License for Vamorolone to Catalyst Pharmaceuticals in Deal Valued at up to USD 231 Million Plus Royalties

Santhera announces that it has signed an exclusive license and collaboration agreement for vamorolone in North America with Catalyst Pharmaceuticals.
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April 25, 2023

Santhera Announces Completion of Mid-Cycle Review Meeting by FDA of Vamorolone for Duchenne

Santhera announces completion of vamorolone NDA mid-cycle review meeting by FDA
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January 9, 2023

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

Santhera and ReveraGen Announce FDA Acceptance of New Drug  Application for Vamorolone in Duchenne Muscular Dystrophy
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October 28, 2022

Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone
in Duchenne Muscular Dystrophy

Santhera and ReveraGen submit NDA to FBA for vamorolone in treatment of Duchenne
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October 6, 2022

Santhera Provides Update on Submission of Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy

Santhera Provides Updates on Submission of Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy
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June 30, 2022

Santhera Updates on Ongoing NDA Submission for Vamorolone

On June 29, 2022, Santhera announced that the clinical module of its rolling new drug application (NDA) for vamorolone in Duchenne muscular dystrophy has been submitted to the U.S. Food...
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