Tag Archives: Approves

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 Calquence for Adults with Chronic Lymphocytic Leukemia

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

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 »

FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin

FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin Print this page Friday, June 28, 2019 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small… Read More »

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC

Print this page KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not… Read More »