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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration (FDA) issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy (Duchenne) patient who had received ELEVIDYS (delandistrogene moxeparvovec) gene therapy. The death of this patient was deemed unrela...

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH) (the “Company” or “Delcath”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the Company granted equity awards, previously approved by the Company’s Compensation Committee, as material inducements to three individuals whose employment commenced in June 2025. The grants resulted in the right to purchase 52,500 shares of the Company’s common stock and...

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems (Online Training Course: August 25-26, 2025)" has been added to ResearchAndMarkets.com's offering. This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles / Annexes of the EU's MDR, which require manufacturers to conduct post-market surveillance at the time of approval or clearance or at any time the...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the conditional marketing authorization (CMA) for ELEVIDYS (delandistrogene moxeparvovec) in ambulatory individuals ages three to seven years for the treatment of Duchenne muscular dystrophy (DMD). “While we are disappointed by the CHMP’s negative opinion,...

BALLERUP, Dinamarca--(BUSINESS WIRE)--LEO Pharma, líder mundial en dermatología médica, anunció hoy que la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) aprobó la crema ANZUPGO® (delgocitinib) (20 mg/g) para el tratamiento tópico del eczema crónico de manos (ECM) de moderado a grave en adultos que han presentado una respuesta inadecuada a los corticosteroides tópicos o para quienes no son aconsejables.1 ANZUPGO es un innovador inhibidor tópico de las cinasas Janus (JAK)...

デンマーク、バレルプ--(BUSINESS WIRE)--（ビジネスワイヤ） -- 医療用皮膚科学のグローバルリーダーであるレオ ファーマは、米国食品医薬品局（FDA）がANZUPGO® （デルゴシチニブ）クリーム（20 mg/g）を、中等度から重度の慢性手湿疹（CHE）に対する外用治療薬として、外用コルチコステロイドが効果不十分、または使用が望ましくない成人を対象に承認したと発表しました。1 ANZUPGOは、慢性手湿疹を有する成人を対象とした、ステロイドを含まない外用のパンヤヌスキナーゼ（JAK）阻害剤という革新的な治療薬です。1ANZUPGOはJAK-STAT経路を阻害し、JAK1、JAK2、JAK3、およびチロシンキナーゼ2（TYK2）の活性を特異的にブロックすることで、慢性手湿疹の発症および再燃に重要な役割を果たす多様な炎症反応を抑制します。1,2,4 ANZUPGOのFDA承認は、レオ ファーマが米国市場での存在感を拡大し、皮膚の健康に意義あるイノベーションをもたらすという戦略において、重要な節目となります。レオ ファーマは、米国の患者にANZUPGOを届ける準備の一環と...

BALLERUP, Dinamarca--(BUSINESS WIRE)--A LEO Pharma, líder global em dermatologia médica, anunciou hoje que a FDA (Agência de Alimentos e Medicamentos dos EUA) aprovou o ANZUPGO® (delgocitinibe) em creme (20 mg/g) para tratamento tópico do eczema crônico das mãos (CHE) moderado a grave em adultos que não responderam adequadamente a corticosteroides tópicos ou para quem seu uso não é indicado.1 O ANZUPGO é um inovador inibidor tópico pan-Janus quinase (JAK), livre de esteroides, indicado para adu...

丹麥巴勒魯普--(BUSINESS WIRE)--(美國商業資訊)-- 醫學皮膚科領域的全球領導者LEO Pharma今日宣布，美國食品藥物管理局(FDA)已核准ANZUPGO® (delgocitinib)乳膏(20 mg/g)用於局部治療那些局部皮質類固醇療效不佳或不適合使用局部皮質類固醇的成人病患的中重度慢性手部濕疹(CHE)。1 ANZUPGO是一款創新的不含類固醇局部泛Janus激酶(JAK)抑制劑，適用于成人CHE病患。1ANZUPGO透過抑制JAK-STAT通路，特異性阻斷JAK1、JAK2、JAK3和酪氨酸激酶2 (TYK2)的活性，從而抑制在CHE發病及後續發作中起關鍵作用的多種發炎反應。1,2,4 ANZUPGO獲FDA核准，代表LEO Pharma策略的重要里程碑，該策略旨在擴大其在美國市場的業務版圖，並為皮膚健康領域帶來有意義的創新。為將ANZUPGO帶給美國病患，LEO Pharma已大幅升級關鍵職能部門的營運，包括將銷售團隊規模擴大50%。 LEO Pharma執行長Christophe Bourdon表示：「ANZUPGO是我們將市場實際需求轉化為藥物的典...

BALLERUP, Dänemark--(BUSINESS WIRE)--LEO Pharma, ein weltweit führendes Unternehmen im Bereich der medizinischen Dermatologie, gab heute bekannt, dass die US-amerikanische Arzneimittelbehörde FDA (Food and Drug Administration) ANZUPGO ® (Delgocitinib) Creme (20 mg/g) für die topische Behandlung von mittelschwerem bis schwerem chronischem Handekzem (CHE) bei Erwachsenen zugelassen hat, die auf topische Kortikosteroide unzureichend angesprochen haben oder für die topische Kortikosteroide nicht ge...