Tag Archives: Approval

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 »

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 »