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 Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation

FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation Print this page Dublin, Ireland – 2 July 2020: Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved Byfavo (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or… Read More »

FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer

FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer Print this page South San Francisco, CA — June 29, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo, a fixed-dose combination (FDC) of Perjeta® (pertuzumab)… Read More »

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis Print this page SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for… Read More »

FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta

FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta Print this page NEW YORK–(BUSINESS WIRE)– June 11, 2020 — Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile… Read More »

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer Print this page BOTHELL, Wash.–(BUSINESS WIRE) April 17, 2020 — Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable… Read More »

FDA Approves Jelmyto (mitomycin gel) for Treatment of Low-Grade Upper Tract Urothelial Cancer

FDA Approves Jelmyto (mitomycin gel) for Treatment of Low-Grade Upper Tract Urothelial Cancer Print this page April 15, 2020 — Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cancer of the lining of the urinary system. “Although… Read More »