Tag Archives: Approves

FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

Print this page TARRYTOWN, N.Y. and PARIS, May 26, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not… Read More »

FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty Print this page BUFFALO GROVE, Ill., May 4, 2020 /PRNewswire/ — Tolmar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for Fensolvi (leuprolide acetate) for injectable suspension for the treatment… Read More »

FDA approves Verily’s Study Watch to monitor cardiovascular conditions

Verily Life Sciences has received a new clearance from the Food and Drug Administration allowing the use of its Study Watch to monitor patients with cardiovascular conditions. The federal agency provided a 510(k) clearance for the Study Watch with Irregular Pulse Monitor, enabling the device to be used with patients older than age 22 who… Read More »

FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia

FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia Print this page PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company’s… Read More »

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN) Print this page DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal… Read More »