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Data from international public/private partnership leads to the first therapy for Duchenne muscular dystrophy approved by both EMA and FDA.
Rockville, MD, USA, December 22, 2023
The EMA approved AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD), ages 4 years and older on 18 December 2023. The US FDA previously approved AGAMREE for DMD (26 October 2023). This makes AGAMREE the first
Vamorolone NDA mid-cycle review meeting by FDA completed
Pratteln, Switzerland, and Rockville, MD, USA, April 25, 2023
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the U.S. Food and Drug Administration (FDA) of the new drug application (NDA)
Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, March 2, 2023
Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, October 31, 2022
Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Validation confirms that the submission is complete and
Santhera and ReveraGen Announce Presentations on Long-Term Efficacy and Bone Health in DMD During Vamorolone Treatment at the 2022 World Muscle Society Congress
Pratteln, Switzerland, and Rockville, MD, USA, October 10, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of data relating to long-term efficacy, tolerability and the impact of vamorolone on bone health in patients with Duchenne muscular dystrophy (DMD)
Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, October 3, 2022
Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
JAMA Neurology Publishes Positive Pivotal Clinical Trial with Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, September 1, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen (US: Private) announce that JAMA Neurology has published positive results of the 24-week primary efficacy and safety analysis from the VISION-DMD study evaluating vamorolone, an investigational
Santhera and ReveraGen Announce First Participant Dosed in FDA-funded Phase 2 Pilot Study with Vamorolone in Becker Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, August 22, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the first patient has been dosed in a Phase 2 pilot study to assess vamorolone in Becker muscular dystrophy (BMD), funded by
Santhera and ReveraGen to Present New Data with Vamorolone at 2022 Parent Project Muscular Dystrophy Conference
Pratteln, Switzerland, and Rockville, MD, USA, June 9, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of new data with vamorolone in Duchenne muscular dystrophy (DMD).
Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy
Pratteln, Switzerland, March 29, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne