Tag Archives: Approves

FDA Approves Sklice (ivermectin) Lotion for Nonprescription Use to Treat Head Lice

October 27, 2020 — Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older… Read More »

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

PRINCETON, N.J.–(BUSINESS WIRE) October 2, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural… Read More »

FDA Approves Bausch + Lomb Alaway Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%

LAVAL, QC and DEER PARK, Ill., Sept. 25, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc. (NASDAQ: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Alaway® Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100), as… Read More »

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency Print this page DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved… Read More »

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne Print this page Lainate, Italy – August 27, 2020 – Cassiopea SpA (SIX: SKIN), today announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Notwithstanding acne being the… Read More »