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 »

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma

Print this page ALAMEDA, Calif.–(BUSINESS WIRE)–Jan. 14, 2019– Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in… 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 »

KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)

Print this page CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of Apadaz, an immediate release (IR)… Read More »

AstraZeneca, Merck's Lynparza plows ahead in ovarian cancer with $1B-plus approval, phase 3 data

The year may be winding down, but AstraZeneca and Merck’s Lynparza sure isn’t. It picked up a blockbuster new approval late Wednesday and followed up the act by posting positive phase 3 data Thursday morning. U.S. regulators green-lighted the fast-growing PARP inhibitor in BRCA-mutated ovarian cancer patients who’ve responded partially or completely to an initial… Read More »