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SANTA CLARA, Calif.--(BUSINESS WIRE)--Coredio, a digital health company developing the first software-as-a-medical-device (SaMD) platform dedicated to heart failure (HF) hemodynamic assessment, today announced that the U.S. Food and Drug Administration has granted its Cardiac Performance Simulation Engine (CPSE™) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheter...

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). The new Prescription Drug User Fee Act (PDUFA) target action date is November 1...

PLAINVIEW, N.Y.--(BUSINESS WIRE)--Acupath Laboratories announced today the integration of the ArteraAI Prostate Test into its diagnostic workflows, allowing for fast and convenient delivery of treatment insights. The ArteraAI Prostate Test is an advanced risk stratification tool to help personalize and optimize treatments for patients with localized prostate cancer. Unlike many other laboratory-developed tests, the ArteraAI Prostate Test is an AI test that analyzes the digital pathology images...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present 38 abstracts, as well as one oral presentation in partnership with Pfizer, showcasing advances in methylation-based tumor classification and liquid biopsy technology at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois taking place May 29 – June 2, 2026. Key data that will be prese...

GILBERT, Ariz.--(BUSINESS WIRE)--First International Bank & Trust announces the launch of its 12th Annual Live First Community Giving Campaign....

LILLE, France--(BUSINESS WIRE)--Alzprotect today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for AZP2006 (Ezeprogind®) for the treatment of Progressive Supranuclear Palsy (PSP). FDA clearance permits the Company to begin clinical development of AZP2006 in the United States. “FDA IND clearance is a pivotal step in our PSP program,” said Philippe Verwaerde, PhD, President & Chief science Officer. “We can now e...

FRANKFURT, Germany & RALEIGH, N.C.--(BUSINESS WIRE)--Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced the presentation of new research at the World Parkinson Congress (WPC) 2026 that uncovers the multifaceted burden of "OFF" episodes in Parkinson's disease (PD). The qualitative literature review demonstrates that these episodes are not only a re-emergence of motor symptoms, but also a complex mix of debilitating motor and non-motor symptoms that impact...

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that data from HERIZON-GEA-01 were published in The New England Journal of Medicine and will be presented in an oral presentation (Rapid Oral Abstract: 4010) at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2026, in Chicago. The HERIZON-GEA-01 clinical trial evaluated ZIIHERA® (zanidatamab) plus chemotherapy, with and without...

SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Patent Application No. 19/253,088, titled “Biphenyl Sulfonamide Compounds for the Treatment of Kidney Diseases or Disorders,” directed to certain methods of using FILSPARI® (sparsentan) in IgA nephropathy. Upon issuance, the patent is expected to provide U.S. patent coverage for certain methods of using sparsentan...

COCOA BEACH, Fla. & SEATTLE--(BUSINESS WIRE)--Alesis LLC, the U.S. distributor of the Alesis OSA1™ medical device, today announced a joint venture partnership with Dr. Lyly Fisher, DDS, Diplomate, ABDSM, ASBA -- a dual board-certified sleep dentist with offices in Seattle and Renton, Washington. Dr. Fisher is the first sleep dentist in the Seattle area to offer Alesis OSA1, a breakthrough non-surgical treatment for patients with obstructive sleep apnea (OSA) who cannot tolerate CPAP therapy. Th...