NDA News-CliniExpert

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

BOSTON, Massachusetts and Cambridge, UK – June 19, 2025 – Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in a

FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection

FOSTER CITY, Calif.--(BUSINESS WIRE) June 18, 2025 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir)—the compa

FDA Approves Andembry (garadacimab-gxii) for Prophylaxis to Prevent Attacks of Hereditary Angioedema

KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ -- Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) approved Andembry (garadacimab-gxii), the only treatment

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