FDA
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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SON-1010 is being studied as a combination therapy with trabectedin (Yondelis®), the first FDA-approved treatment for two types of advanced soft tissue sarcoma after failure of standard chemotherapy, due to the potential for immune mechanism synergies and enhancement of progression-free survival (PFS) The Safety Review Committee found no unexpected toxicities in early dosing of SON-1010…
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Excerpt from the Press Release: BOSTON & SHENZHEN, China–(BUSINESS WIRE)–Signet Therapeutics, a clinical-stage biotech company leveraging organoid- and AI-driven cancer drug discovery, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIGX1094, the world’s first potential targeted therapy for diffuse gastric cancer (DGC). This designation is designed to accelerate…
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Topline data from an interim analysis of the fourth cohort of its Phase 1b Multiple-Ascending Dose (MAD) clinical trial showed continued mechanistic dose response Exploratory results of imaging-based biomarkers continued to show reduction in height-adjusted total kidney volume (htTKV) growth rate Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement…
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January 30, 2025 Alterity Therapeutics – Clinically Meaningful Benefit Observed at Both ATH434 Doses Studied – – Achieved Statistical Significance with Up to 48% Slowing of Clinical Progression on UMSARS Rating Scale – – Key MRI Biomarker Shows Iron Stabilization in MSA Affected Brain Regions – – ATH434 Demonstrated a Favorable Safety Profile – Excerpt…
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Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases based on agonism of TIM (T cell/transmembrane, immunoglobulin, and mucin receptor), today announced the dosing of first subject with its investigational…
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