FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)

CAMBRIDGE, Mass. & SALISBURY, England, July 7, 2025 (BUSINESS WIRE) -- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved E

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FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple Myeloma

TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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