Tag Archives: Approves

FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available

FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available Print this page July 2, 2020 — ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg… Read More »

FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain

FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain Print this page MALVERN, Pa., Feb. 20, 2020 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA)… Read More »

FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta

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 »

FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes

Print this page PLAINSBORO, N.J., Jan. 6, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1 Fiasp is the first and only fast-acting mealtime insulin injection that does not… Read More »

FDA Approves Vascepa (icosapent ethyl) to Reduce Cardiovascular Risk

Print this page DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 13, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication and label expansion for Vascepa (icosapent ethyl) capsules. After more than a decade of development and testing, Vascepa is now the first… Read More »