NDA News-CliniExpert

FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis

October 9, 2025 -- Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for idiopathic pulmonary fibrosis

FDA Approves Lasix ONYU (furosemide) for Treatment of Edema in Heart Failure

Burlington, Massachusetts, October 8, 2025 – SQ Innovation, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its drug-device combination Lasix ONYU (furosemide inject

FDA Approves Eydenzelt (aflibercept-boav), a Biosimilar to Eylea

INCHEON, South Korea, Oct. 9, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), biosimilar referencing Ey

FDA Approves Rhapsido (remibrutinib) for the Treatment of Chronic Spontaneous Urticaria

EAST HANOVER, N.J., Sept. 30, 2025 -- Novartis announced today that Rhapsido (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic

FDA Approves Enoby (denosumab-qbde), a Biosimilar to Prolia

Budapest, Hungary and London, UK, 29 September 2025 -- Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) an

FDA Approves Xtrenbo (denosumab- qbde), a Biosimilar to Xgeva

Budapest, Hungary and London, UK, 29 September 2025 -- Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) an

FDA Approves Qivigy (immune globulin intravenous, human-kthm) for Primary Humoral Immunodeficiency

September 29, 2025 -- Kedrion Biopharma announced today that it has received FDA approval for Qivigy®, a new 10% Immunoglobulin for intravenous use, indicated for treatment of adults with Primary humo

FDA Approves Clotic (clotrimazole otic solution), First Treatment with Clinical Evidence for Fungal Ear Infections

September 2025: Madrid, Spain, 26 September 2025 -- Laboratorios Salvat, S.A. ("Salvat") announced today that the U.S. Food and Drug Administration (FDA) has approved Clotic (clotrimazole ot

FDA Approves Inluriyo (imlunestrant) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets), an

FDA Grants Accelerated Approval to Forzinity (elamipretide hydrochloride) for the Treatment of Barth Syndrome

NEEDHAM, Mass., Sept. 19, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercializ

FDA Approves Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection Formulation of Keytruda for Use in Solid Tumors

RAHWAY, N.J. -- (BUSINESS WIRE) September 19, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has appr

FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease

HENDERSON, Nev.--(BUSINESS WIRE) September 15, 2025 -- Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiova