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Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn
RAHWAY, N.J.--(BUSINESS WIRE)--The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy has been voluntarily withdrawn. The decision to withdraw the BLA is based on discussions wit...
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Adicet Bio to Host Webcast to Present Prula-cel (formerly ADI-001) Clinical Data in Patients with Systemic Lupus Erythematosus with or without Lupus Nephritis
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical-stage biotechnology company discovering and developing allogeneic gamma delta CAR-T cell and in vivo CAR-T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the Company will report clinical data from the Phase 1 study evaluating prulacabtagene leucel (prula-cel) as a potential treatment for patients with systemic lupus erythematosus with or without lupus nephritis...
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InSilicoTrials Joins ARPA-H CIRCLE Team to Build a Regulatory-Ready Platform for Critical Illness Digital Twins
WILMINGTON, Del.--(BUSINESS WIRE)--InSilicoTrials, a cloud-based platform for AI and computational modeling and simulation in healthcare, today announced that it is a subawardee on a team led by Sage BioNetworks, which has received an award from the Advanced Research Projects Agency for Health (ARPA-H) under the Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) program. Critical illness, including severe infections, traumatic injuries and complications of c...
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Corsera Health Named a 2026 “Endpoints 11” Honoree
BOSTON--(BUSINESS WIRE)--Corsera Health, Inc., a clinical-stage company leading the future of cardiovascular health through prediction and prevention, announced that it has been named to the 2026 “Endpoints 11” list of the most promising startups in the biopharmaceutical industry. The annual Endpoints News honor recognizes private companies that are pursuing the most ambitious scientific breakthroughs of tomorrow, backed by expert leadership and strong investor confidence. “At Corsera Health, w...
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Lōkahi Therapeutics™ Expands ai2 Pipeline™ Program Through Collaboration with Pepperdine E2B™
RUTHERFORD, N.J. & LA JOLLA, Calif.--(BUSINESS WIRE)--Lōkahi Therapeutics™ partners with Pepperdine E2B™ to expand ai² Pipeline™, engaging MBA students in evaluating biopharmaceutical assets....
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Breast Cancer Continues to Impact Communities; Austin Rallies Together to Take Action at Susan G. Komen® Austin MORE THAN PINK Walk
AUSTIN, Texas--(BUSINESS WIRE)--Susan G. Komen®, the world's leading breast cancer organization, today announced it will host the Austin MORE THAN PINK Walk bringing together survivors, those living with metastatic breast cancer, families and supporters for a day of purpose and action. The event, taking place on Sunday, October 25, 2026, will raise critical funds to accelerate lifesaving research, expand patient support services, support critical public policy efforts and help ensure every pers...
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Sarepta Therapeutics Announces Presentations at 2026 World Muscle Society Annual Congress
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will present new data from its portfolio of treatments for Duchenne muscular dystrophy at the 31st Annual Congress of the World Muscle Society (WMS), taking place Sept. 29 - Oct. 3, in Hiroshima, Japan. Data at WMS includes a late-breaking poster presentation on delandistrogene moxeparvovec efficacy and safety in older, ambulatory Duchenne patients in Sarepta’...
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Croma-Pharma Introduces saypha® volume prime Lidocaine
LEOBENDORF, Austria--(BUSINESS WIRE)--Croma-Pharma introduces saypha® volume prime Lidocaine, a cross-linked hyaluronic acid dermal filler that replaces saypha® volume Lidocaine within the company's saypha® portfolio. The new product offers physicians a more versatile solution with expanded indications for both midface volumization and nasolabial folds, backed by strong clinical data. 1,2 saypha® volume prime Lidocaine demonstrated non-inferiority to comparatora in a randomized, subject- and ev...
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Quanterix Delivers on Spatial Biology Content Innovation Commitments at ESSB 2026
BILLERICA, Mass.--(BUSINESS WIRE)--Quanterix Corporation (NASDAQ: QTRX) today reported significant progress on the Content Innovation Engine it introduced at the American Association for Cancer Research (AACR) Annual Meeting 2026, highlighting new updates at the European Society for Spatial Biology (ESSB) September 28-October 1, 2026. This progress underscores Quanterix's growing leadership in spatial biology content, delivering the assays researchers need to do more pivotal work. Built on the...
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Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein, a First-in-Class adjunct in the real-time intraoperative visualization of nerves during head and neck surgical procedures in adults
SAN DIEGO--(BUSINESS WIRE)--Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein...