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 »