Tag Archives: Approves

FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism

FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism Print this page March 27, 2019 — The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders… Read More »

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease Print this page ARDSLEY, N.Y.–(BUSINESS WIRE) December 21, 2018 –Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. OFF… Read More »

U.S. FDA approves Alexion Pharma's blood disorder drug

(Reuters) – The U.S. Food and Drug Administration has approved Alexion Pharmaceuticals Inc’s blood disorder drug Ultomiris, the pharma regulator’s website showed on Friday. The drug aims to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, life-threatening disorder in which red blood cells divide prematurely. Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila… Read More »

FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia

FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia Print this page November 21, 2018 — The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75… Read More »

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer Print this page November 2, 2018 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer… Read More »