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DermaSensor startet in Deutschland über die DERMALYTICA-Sparte von ContraCare und expandiert nach Erhalt der CE-Kennzeichnung der Klasse IIb und der Zusammenarbeit mit dem NHS in Europa

MIAMI & NÜRNBERG, Deutschland--(BUSINESS WIRE)--DermaSensor Inc., ein führender Anbieter von KI-gestützter Technologie zur Einschätzung des Hautkrebsrisikos, gab heute die Markteinführung von DermaSensor in Deutschland durch eine Vertriebsvereinbarung mit der ContraCare GmbH bekannt. Dies stellt einen bedeutenden Meilenstein in der internationalen Expansion von DermaSensor dar, nachdem das Unternehmen kürzlich die CE-Kennzeichnung der Klasse IIb gemäß der Medizinprodukteverordnung (MDR) der Eur...
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Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Formulation of YUSIMRY®, a Biosimilar to Humira®

CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced that the U.S. Food and Drug Administration (“FDA”) has approved a high-concentration formulation (“HCF”) for YUSIMRY® (adalimumab-aqvh), as an interchangeable biosimilar to Humira®. Emerge Bioscience Pte. Ltd. (“Emerge”) holds the...
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LIB Therapeutics and Sun Pharma Announce Global Licensing, Commercialization and Manufacturing Agreement for Lerodalcibep, a Novel PCSK9 Inhibitor, Ex-US and China; Lerodalcibep (Lyrokaul®) Approved in the EU

MUMBAI, India & CINCINNATI--(BUSINESS WIRE)--Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715; together with its subsidiaries and/or associated companies, “Sun Pharma”) and LIB Therapeutics Inc. (“LIB”) today announced: An exclusive licensing agreement granting Sun Pharma rights to commercialize and manufacture lerodalcibep worldwide, excluding the United States and China. Lyrokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lo...
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U.S. FDA Accepts sNDA and Grants Priority Review to Bayer’s Lynkuet® (elinzanetant) for a New Indication for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Endocrine Therapy Related to Breast Cancer

WHIPPANY, N.J.--(BUSINESS WIRE)--Today Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation for Lynkuet® (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer. First approved by the FDA in October 2025 for the treatment of moderate to sev...
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Tempus Receives FDA Clearance for its ECG-MR AI Product Designed to Identify Undiagnosed Mitral Regurgitation

CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR). MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as no...
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DermaSensor Launches in Germany with ContraCare’s DERMALYTICA Division, Beginning European Expansion Following Class IIb CE Mark and NHS Collaboration

MIAMI & NUREMBERG, Germany--(BUSINESS WIRE)--DermaSensor Inc., a leader in AI-powered skin cancer risk detection technology, today announced the commercial launch of DermaSensor in Germany through a distribution agreement with ContraCare GmbH. The launch represents a significant milestone in DermaSensor’s international expansion following its recent Class IIb CE Mark under the European Union Medical Device Regulation (MDR) and collaboration with the National Health Service (NHS) in the United K...
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QIAGEN Completes U.S. QIAstat-Dx Bloodstream Infection Portfolio With FDA Clearance of New Bacteria Detection Panel

GERMANTOWN, Md. & VENLO, Netherlands--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that U.S. laboratories now have access to the complete QIAstat-Dx bloodstream infection portfolio following clearance of a new panel by the U.S. Food and Drug Administration (FDA). The new panel detects gram-negative bacteria and antibiotic resistance markers in about one hour, complementing the recently FDA-cleared QIAstat-Dx panel for gram-positive bacteria and fungi....
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Riassunto: Mirum Pharmaceuticals e Incyte annunciano l’approvazione da parte dell’FDA statunitense di Atebrioz™ (zilurgisertib) per pazienti adulti e pediatrici affetti da fibrodisplasia ossificante progressiva (FOP)

FOSTER CITY, California e WILMINGTON, Delaware--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) e Incyte (Nasdaq: INCY) oggi hanno annunciato che la Food and Drug Administration (FDA) statunitense ha approvato le compresse di Atebrioz™ (zilurgisertib) per ridurre il volume della nuova ossificazione eterotopica totale in pazienti adulti e pediatrici di almeno 12 anni di età affetti da fibrodisplasia ossificante progressiva. Il testo originale del presente annuncio, redatto nella ling...
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Samenvatting: Mirum Pharmaceuticals en Incyte maken bekend dat de Amerikaanse FDA goedkeuring heeft verleend voor Atebrioz™ (zilurgisertib) voor volwassen en pediatrische patiënten met fibrodysplasia ossificans progressiva

FOSTER CITY, Calif. & WILMINGTON, Del.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) en Incyte (Nasdaq:INCY) hebben vandaag bekendgemaakt dat de Amerikaanse Food and Drug Administration (FDA) Atebrioz™ (zilurgisertib) tabletten heeft goedgekeurd voor het verminderen van het totale volume aan nieuwe heterotope ossificatie (HO) bij volwassen en pediatrische patiënten van 12 jaar en ouder met fibrodysplasia ossificans progressiva (FOP). Deze bekendmaking is officieel geldend in de or...
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Mirum Pharmaceuticals et Incyte annoncent l’autorisation par la FDA américaine d’Atebrioz™ (zilurgisertib) pour les patients adultes et pédiatriques atteints de fibrodysplasie ossifiante progressive

FOSTER CITY, Californie et WILMINGTON, Delaware--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq : MIRM) et Incyte (Nasdaq : INCY) ont annoncé aujourd’hui que la Food and Drug Administration (FDA) américaine avait approuvé les comprimés d’Atebrioz™ (zilurgisertib) pour réduire le volume total des nouvelles ossifications hétérotopiques (HO) chez les patients adultes et pédiatriques âgés de 12 ans et plus atteints de fibrodysplasie ossifiante progressive (FOP). La posologie recommandée d’Ate...