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Pulmonary Diseases

FDA Grants Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

RIDGEFIELD, Conn., Oct. 10, 2019 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Regulatory applications have been …

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Savara Announces FDA Response From Type C Meeting on Molgradex for aPAP Development Program

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the response from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Molgradex development program for autoimmune pulmonary alveolar proteinosis (aPAP). Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). …

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FibroGen Announces Publication of Positive Pamrevlumab Efficacy and Safety Data for the Praise Phase 2 Study in Idiopathic Pulmonary Fibrosis

SAN FRANCISCO, Sept. 30, 2019 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced publication in The Lancet Respiratory Medicine of positive results from the company’s PRAISE Phase 2 clinical study of the efficacy and safety of pamrevlumab, a fully human recombinant monoclonal antibody against connective tissue growth factor (CTGF), for treatment …

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AzurRx BioPharma Announces Positive Results from Phase 2 Trial of MS1819 in Cystic Fibrosis Patients

NEW YORK, Sept. 25, 2019 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced positive safety results from its Phase II OPTION Clinical Trial of MS1819 for the treatment of exocrine pancreatic insufficiency …

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FDA Approves Ofev, the First and Only Therapy to Slow the Rate of Decline in Pulmonary Function in Patients with Sclerosis-Associated ILD

Ridgefield, Conn., September 06, 2019 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is already approved in the …

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FDA Grants Orphan Drug Designation to Acceleron’s Sotatercept for Treatment of Pulmonary Arterial Hypertension

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary …

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AstraZeneca’s Investigational Triple Combo Therapy Meets its Primary Endpoint in Phase 3 COPD Trial

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive results from the Phase III ETHOS trial for triple-combination therapy PT010 in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). At the standard budesonide dose, PT010 (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with …

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FDA Accepts Vertex’s NDA for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combo Treatment for Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. The FDA has granted Priority Review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action …

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Nabriva’s Xenleta Receives FDA Approval for Treatment of Community-Acquired Bacterial Pneumonia

DUBLIN, Ireland, Aug. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and …

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CureVac and Yale University Partner for Discovery Research in mRNA-Based Lung Therapy Candidates

TÜBINGEN, Germany and BOSTON, Aug. 13, 2019 (GLOBE NEWSWIRE) — CureVac AG, a fully integrated biopharmaceutical company pioneering the field of mRNA-based drugs, announced today it has entered into a Collaborative Research Agreement (“CRA”) with Yale University for discovery research into mRNA-based pulmonary therapeutic candidates.  The exclusive CRA covers the …

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