NDA News-CliniExpert

FDA Approves Zusduri (mitomycin) for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J. -- (BUSINESS WIRE) -- Jun. 12, 2025-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and sp

FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer

NEW YORK--(BUSINESS WIRE) June 11, 2025 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U

FDA Approves Enflonsia (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants

RAHWAY, N.J.--(BUSINESS WIRE) June 9, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Enflonsi

FDA Approves Widaplik (telmisartan, amlodipine and indapamide) for the Treatment of Hypertension

London, UK, Boston, MA, 9 June 2025 -- George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, today announces that the US Food and Drug

FDA Approves mNEXSPIKE (COVID-19 Vaccine, mRNA) to Prevent COVID-19

CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 -- Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine agains

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

GENEVA--(BUSINESS WIRE) May 28, 2025 -- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the U.S. Food and Drug Administration (FDA) ha

FDA Approves Yutrepia (treprostinil) Inhalation Powder for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

MORRISVILLE, N.C., May 23, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, ann

FDA Approves Starjemza (ustekinumab-hmny), a Biosimilar to Stelara

Guangzhou and London – May 27, 2025 – Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceut

FDA Approves Nuvaxovid (COVID-19 Vaccine, Adjuvanted) to Prevent COVID-19

GAITHERSBURG, Md., May 19, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for N

FDA Grants Accelerated Approval to Emrelis (telisotuzumab vedotin-tllv) for Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administ

FDA Approves Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib tablets) for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

BOSTON -- (BUSINESS WIRE) -- May 8, 2025 -- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today

FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine

DURHAM, N.C., April 30, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other d