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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

March 17, 2022

Santhera and ReveraGen Present Efficacy and Safety Data with Vamorolone in Duchenne

Santhera and ReveraGen have shared an update on the evidence of clinical efficacy and safety of vamorolone in participants with Duchenne, based on the positive outcome of the pivotal Phase 2b VISION-DMD study and additional Phase…

Learn More

November 23, 2021

Santhera and ReveraGen Announce Positive Topline Results with Vamorolone after Completion of the VISION-DMD Study

PPMD is pleased to share the announcement from Santhera Pharmaceuticals and ReveraGen BioPharma, Inc., of new topline results after completion of the VISION-DMD study at week 48. VISION-DMD was a pivotal double-blind Phase 2b study…

Learn More