Tag Archives: Approves

FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy Print this page DUBLIN, July 22, 2020 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of… Read More »

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 Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers Print this page INDIANAPOLIS, May 8, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with… Read More »

FDA Approves Retevmo for Certain Lung, Thyroid Cancers

MONDAY, May 11, 2020 — Retevmo (selpercatinib) capsules have been approved to treat patients with non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and other thyroid cancers with an alteration in the “rearranged during transfection” (RET) gene, the U.S. Food and Drug Administration announced Friday. Retevmo was approved for adults with metastatic NSCLC and… Read More »

FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma

FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma Print this page HORSHAM, Pa., May 1, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. Darzalex Faspro™ is approved in four regimens… Read More »

FDA Approves Zejula (niraparib) as the Only Once-Daily PARP Inhibitor in First-Line Monotherapy Maintenance Treatment for Women with Platinum-Responsive Advanced Ovarian Cancer Regardless of Biomarker Status

Print this page London UK — 29 April 2020 — Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend… Read More »