Tag Archives: Approval

Eversense Implantable Glucometer Gets FDA Approval as Alternative to Finger Tests

Senseonics, a company out of Germantown, Maryland, won FDA approval for its Eversense continuous glucose monitoring system. The system is intended to be used instead of traditional finger prick tests to make diabetes-related decisions. This is a giant step for the company, which has developed a technology that combines a tiny implant with a wearable… Read More »

Feds continue to refuse to make CBD legal without explicit FDA approval

(Photo: Adobe Stock) This week, the Food and Drug Administration (FDA) reiterated that hemp-derived cannabidiol, also known as CBD oil, is illegal to add to food, beauty or health products without prior FDA approval, or to make health claims for CBD. Despite the big farm bill President Trump signed off on this week which designates… Read More »

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns

Print this page DUBLIN–(BUSINESS WIRE)–Dec. 27, 2018– Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder… Read More »