The investigational product is an extended-release tablet formulation of diazoxide chloride, the crystalline salt of diazoxide.
The updated label now includes 3-year data from AURORA 2, a double-blind, placebo-controlled extension study.
The conversion from accelerated to traditional approval was based on data from the phase 3 innovaTV 301 clinical trial.
The closed-loop feature of the Inceptiv SCS senses neural responses and is able to automatically adjust stimulation in real time.
A review of recent medical-related criminal activity related to the unlawful dispensing and distribution of prescription medications.
The approval was based on data from an open-label clinical trial that included 33 virologically-suppressed pregnant adults.
A phase 3, open-label study (MEND-PNPO) evaluating MC-1 in patients with confirmed PNPO deficiency (via genetic analysis) is currently in the works.
Rezenopy is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
Prademagene zamikeracel is an autologous cell therapy that consists of epidermal sheets that deliver functional COL7A1 genes into the patient’s own skin cells to enable normal type VII collagen expression and facilitate wound healing.
The Company is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life.
