January 30, 2024

Watch: Navigating Steroid Choices – Understanding the Process, Pathways, and Policies (Webinar Recording)

Last week, PPMD was joined by Kathy Mathews, MD (Neurologist), Christina Trout, RN, MSN (Clinic Coordinator), and Rachel Kinn, PharmD, BCPPS (Pharmacist) from the University of Iowa to discuss decision making regarding steroids. In recent…

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December 1, 2023

Watch: AGAMREE® Approval with Catalyst Pharmaceuticals, Inc. (Webinar Recording)

PPMD was recently joined by Catalyst Pharmaceuticals to review the recent FDA approval of AGAMREE (vamorolone), a new steroid approved for the treatment of Duchenne.  Amy Grover, Catalyst’s Senior Director of Patient Advocacy, introduced the…

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November 6, 2023

WATCH: AGAMREE Approval – What this means for you & your family (Webinar recording)

PPMD was recently joined by Dr. Aravindhan Veerapandiyan of Arkansas Children’s Hospital to discuss the FDA’s recent approval of AGAMREE (vamorolone), a new steroid approved for the treatment of Duchenne muscular dystrophy in individuals aged…

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October 26, 2023

FDA Grants Approval to AGAMREE® (Vamorolone)

PPMD is excited to learn that the FDA has granted approval to AGAMREE® (vamorolone), a dissociative steroid indicated for individuals diagnosed with Duchenne muscular dystrophy from age 2 years and older.  AGAMREE® is a first-in-class…

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October 13, 2023

Santhera Receives Positive European Medicines Agency (EMA) CHMP Opinion Recommending Approval of Vamorolone in European Union

Santhera Pharmaceuticals has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in favor of approval of vamorolone (AGAMREE®) for the treatment of Duchenne muscular dystrophy…

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June 21, 2023

Santhera announces exclusive North America license agreement with Catalyst Pharmaceuticals for vamorolone

PPMD has learned that Santhera Pharmaceuticals has entered into an agreement granting exclusive North America license for vamorolone to Catalyst Pharmaceuticals. Santhera will continue to keep commercialization rights in Europe, while Catalyst will obtain commercialization…

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January 9, 2023

Update from Santhera & ReveraGen: FDA Acceptance of New Drug Application for Vamorolone in Duchenne

PPMD is excited to learn from Santhera and ReveraGen that the FDA has accepted the New Drug Application (NDA) for vamorolone, an investigational dissociative steroid for individuals with Duchenne. Under the Prescription Drug User Fee…

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August 22, 2022

Santhera & ReveraGen Announce First Participant Dosed in Phase 2 Pilot Study with Vamorolone in Becker

Today Santhera and ReveraGen announced they have dosed the first participant in their Phase 2 study with Vamorolone for individuals with Becker muscular dystrophy. The small pilot study was funded through an FDA grant and…

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June 29, 2022

Santhera Updates on Ongoing NDA Submission for Vamorolone in Duchenne

Today Santhera shared an update on the timeline for the submission of their New Drug Application (NDA) for Vamorolone, an investigational dissociative steroid for individuals with Duchenne. Santhera expects to complete the submission of their…

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March 30, 2022

Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne

Santhera and ReveraGen have announced 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. This is the first step…

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