News

Next month’s annual conference of the National Organization for Rare Disorders (NORD) in Washington, D.C., couldn’t come at a better time, says Marshall Summar, MD, chairman of NORD’s board of directors. “The pace of discovery in rare diseases has gone from brisk to hypersonic,” Summar told Bionews Services, publisher…

The U.S. Food and Drug Administration (FDA) has agreed to review a request to approve Trevyent (treprostinil) as a treatment of pulmonary arterial hypertension (PAH), United Therapeutics announced in a press release. An FDA decision on this updated New Drug Application (NDA) for Trevyent is expected on or before…

The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for the treatment of people with pulmonary arterial hypertension (PAH). Similar to breakthrough therapy, the designation of breakthrough device is given to medical equipment…