TUESDAY, April 14, 2020 — Koselugo (selumetinib) has received the first approval for treatment of neurofibromatosis type 1 (NF1) in children ages 2 years and older, the U.S. Food and Drug Administration announced Friday. Approved specifically for patients with symptomatic, inoperable plexiform neurofibromas (PNs), Koselugo, a kinase inhibitor, works by blocking a key enzyme to… Read More »
Print this page FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at… Read More »
FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta Print this page WOODCLIFF LAKE, N.J.–(BUSINESS WIRE) February 10, 2020 –Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has received final approval from the U.S. Food and Drug Administration (“FDA”) for its novel product, Pemfexy (pemetrexed for injection),… Read More »
Print this page 21 November 2019 — AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programmes. The approval is based on positive… Read More »
FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions Print this page SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the… Read More »