Tag Archives: Approves

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) — Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Bronchitol… Read More »

FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis

FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis Print this page LEBANON, N.J., Aug. 25, 2020 /PRNewswire/ — Recordati Rare Diseases Inc., today announced the U.S. Food and Drug Administration (FDA) has approved Cystadrops (cysteamine ophthalmic solution) 0.37%. Cystadrops is a new, viscous eye drop solution that depletes corneal cystine crystal… Read More »

FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy

FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy Print this page PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ — NS Pharma, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who… 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 Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause

FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause Print this page BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 29, 2018– TherapeuticsMD, Inc, an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Bijuva (estradiol and progesterone) capsules, 1 mg/100… Read More »

US approves new type of flu drug

U.S. health regulators have approved the first new type of flu drug in two decades. Wednesday’s approval of Xofluza for people age 12 and older comes ahead of the brunt of this winter’s flu season. Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after one just dose. It was… Read More »

FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza

FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza Print this page October 24, 2018 — Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48… Read More »

FDA Approves Third of New Migraine Drugs

Sept. 28, 2018 — The FDA has approved the third of a new type of drug to prevent migraine headaches in adults. Galcanezumab-gnlm (Emgality) targets calcitonin gene-related peptide (CGRP), a molecule that’s produced in nerve cells of the brain and spinal cord. The FDA approved two other CGRP drugs for migraine — erenumab (Aimovig) and fremanezumab-vfrm… Read More »