Tag Archives: pulmonary

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 Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD) Print this page DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for… Read More »

GSK says U.S. FDA wants more information on pulmonary drug

LONDON (Reuters) – GlaxoSmithKline said on Friday that U.S. health authorities had asked for more information about its Nucala drug for use in combating chronic obstructive pulmonary disease (COPD). FILE PHOTO: The GlaxoSmithKline (GSK) logo. March 21, 2018. REUTERS/Loriene Perera/File Photo GSK said it had received a complete response letter (CRL) from the U.S. Food… Read More »