We stand with the Duchenne community in expressing our disappointment regarding the National Institute for Health and Care Excellence's (NICE) recent …
Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular DystrophyAd hoc …
Vamorolone NDA mid-cycle review meeting by FDA completed
Vamorolone NDA mid-cycle review meeting by FDA completedSanthera Pharmaceuticals and ReveraGen BioPharma, Inc announce the successful completion of …
Vamorolone NDA mid-cycle review meeting by FDA completedRead More
Santhera submits marketing authorisation application to the UK MHRA for Valmorolone in Duchenne Muscular Dystrophy.
Santhera submits marketing authorisation application to the UK MHRA for Valmorolone in Duchenne Muscular DystrophyOn March 2, 2023 – Santhera …
Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application …
Edgewise announces FDA authorisation for Phase 2 clinical trial
Edgewise has announced the FDA has authorized Phase 2 clinical trial for the treatment of Duchenne. The Lynx trial is a placebo-controlled trial to …
Edgewise announces FDA authorisation for Phase 2 clinical trialRead More
End of project report summary – Clinical Trials Lectureship (Newcastle)
We are delighted to report the outcomes of our grant for a Clinical Trials Lectureship. The grant, which was supported by a consortium of seven UK …
End of project report summary – Clinical Trials Lectureship (Newcastle)Read More
Santhera and ReveraGen announce positive topline results with Vamorolone after completion of the Vision_DMD Study
Action Duchenne is pleased to share the announcement from Santhera Pharmaceuticals and ReveraGen BioPharma, Inc., of new results after completion of …
Duchenne Science events back on the road in 2020
We've welcomed over 100 people to our Science on Tour events throughout 2019, these empowering and invaluable sessions have been a huge success and we …
Vamorolone gains Promising Innovative Medicine status
We’re happy to announce that the MHRA (the medicines regulator in the UK) has given Promising Innovative Medicine (or PIM) status to Vamorolone as a …
Vamorolone gains Promising Innovative Medicine statusRead More
Latest results from Vamorolone trials
A late-breaking presentation at the 24th International Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark reported top-line data …
Vamorolone trial results published
Earlier this week the results of an early trial of vamorolone in boys with Duchenne have been published in the Neurology scientific journal. …
