FDA
Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026 Trial design allows flexibility to include an experimental arm with checkpoint inhibitor combination Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today…
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First Gene Therapy Trial for Angelman Syndrome -Orphan Drug Designation Granted for MVX-220 Excerpt from the Press Release: MIDDLETON, Mass., Nov. 6, 2025 /PRNewswire/ — MavriX Bio, a clinical-stage biotechnology company focused on the development of transformative genetic therapies for Angelman syndrome (AS), today announced that the first patient has been dosed in the Phase 1/2…
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Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm Company anticipates trial completion in early 2027, and potential updates in…
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– Second generation pulsed field ablation system will be evaluated in paroxysmal and persistent atrial fibrillation patients to gain FDA approval – Excerpt from the Press Release: LAUSANNE, Switzerland and SAN DIEGO, Sept. 18, 2025 /PRNewswire/ — Argá Medtech, developers of the Coherent Sine-Burst Electroporation™ (CSE™) System, a next-generation pulsed field ablation (PFA) system for treating…
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Excerpt from the Press Release: CRANBURY, N.J.–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s pivotal Phase 2 trial of…
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Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Eluciderm, Inc., a clinical-stage pharmaceutical company developing small molecule therapeutics designed to promote healing and regenerative repair of injured tissue, announced today that on June 30, 2025 the company received clearance from the U.S. Food & Drug Administration (FDA) for its Investigational New Drug (IND), ELU42, for a…
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Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Alume Biosciences, a late-clinical stage biotechnology company developing nerve-illuminating technology to enhance surgical safety, today announced the publication of first-in-human data from a Phase 1 clinical trial evaluating bevonescein (ALM-488) in head and neck surgeries. The original research article titled, “Intraoperative Nerve-Specific Fluorescence Imaging in Head and Neck…
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Groundbreaking device sets new standard in the management of patients with an elevated risk of sudden cardiac arrest Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–In a significant leap forward in the care of patients with cardiac disease, Element Science is proud to announce that its innovative Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD) has received…
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Excerpt from the Press Release: PALO ALTO, Calif., April 16, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, following the formation of its proposed joint venture with IPMC Company,…
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Excerpt from the Press Release: SAN FRANCISCO, April 1, 2025 /PRNewswire/ — Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration…
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