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WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer Summary Bayer announced today that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for KERENDIA® (finerenone), which is being investigated for the treatment of adults with chronic kidney disease (CKD) without diabetes who are receiving background standard of care. Key Facts The sNDA was supported by results from the Phase III FIND-CKD trial investigating KERENDIA in adults with CKD without diabete...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TUKYSA® (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer following induction treatment. The approval expands the use of TUKYSA to frontline, an earlier stage of metastatic disease, offering a new chemotherapy...

CRANBURY, N.J.--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated commercial-stage biotechnology company advancing genetic medicines for rare and life-threatening diseases, highlighted key findings and development milestones presented during its October 6 Danon disease investor webinar. The update outlined a defined path to completing the FDA-aligned pivotal Phase 2 trial, highlighted sustained biological activity in longer-term Phase 1 follow-up and reported enco...

LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. ("Owlet" or the "Company") (NYSE: OWLT), the pioneer of smart infant monitoring, today announces a new partnership with VillageFor, a mental health platform for every path to parenthood and beyond, expanding access to mental health support for new and expecting parents. Founded by two mothers who experienced infertility, NICU stays, and postpartum mental health conditions, VillageFor was built around a simple idea: a mom should not have to be in crisis b...

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted plozasiran entry in the Split Real Time Application Review (STAR) pilot program in connection with Arrowhead’s upcoming supplemental new drug application (sNDA) for severe hypertriglyceridemia (sHTG). SHTG is a condition that significantly increases the risk of acute pancreatitis, which is associated with repeated hospital admiss...

NEWTON, Mass.--(BUSINESS WIRE)--Inflammasome Therapeutics today announced that additional analyses from its Phase 2 study of Kamuvudine K8 in geographic atrophy will be presented at the American Academy of Ophthalmology (AAO) Retina Subspecialty Day in New Orleans on Friday 9 October 2026. Liangbo Shen, MD, will present “A Phase 2 Clinical Trial of the Inflammasome Inhibitor Kamuvudine K8 in Geographic Atrophy” at 5.00 pm CT. The six-month Phase 2 study evaluated K8 in 30 participants with bila...

CLAYMONT, Del.--(BUSINESS WIRE)--MRI2CT received FDA 510(k) clearance for NextMR, enabling 3D bone visualization from standard spine MRI....

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., een toonaangevend bedrijf op het gebied van precisie-oncologie voor borstkanker, heeft vandaag aangekondigd dat het tijdens het congres van de European Society for Medical Oncology (ESMO) in 2026, dat plaatsvindt van 23 t/m 27 oktober 2026 in Madrid, nieuw onderzoek zal presenteren. Dit onderzoek betreft de ontwikkeling van een op kunstmatige intelligentie (AI) gebaseerde methode voor digitale pathologie ten behoeve van MammaPrintⓇ. Da...

IRVINE, California y ÁMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., empresa líder en oncología de precisión para el cáncer de mama, anunció hoy que presentará nuevas investigaciones en una sesión oral sobre el desarrollo de un nuevo enfoque de patología digital con inteligencia artificial para MammaPrintⓇ en el Congreso de la Sociedad Europea de Oncología Médica (ESMO) 2026, que se celebrará del 23 al 27 de octubre de 2026 en Madrid. La compañía también presentará dos pósteres adicionales en el mar...

IRVINE, Kalifornien & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., ein führendes Unternehmen im Bereich der Präzisionsonkologie bei Brustkrebs, gab heute bekannt, dass es bei der Tagung der European Society for Medical Oncology (ESMO) vom 23. bis zum 27. Oktober 2026 in Madrid im Rahmen einer Podiumspräsentation zur Entwicklung einer KI-gestützten Methode der digitalen Pathologie für MammaPrintⓇ neue Untersuchungen präsentieren wird. Das Unternehmen wird bei der ESMO zudem zwei zusätzliche Poster...