FDA
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…
Read MoreExcerpt 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,…
Read MoreSON-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…
Read MoreExcerpt 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…
Read MoreTopline 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…
Read MoreJanuary 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…
Read MoreExcerpt 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…
Read More-TYRA appoints urologic oncologist, Erik Goluboff, M.D., as SVP, Clinical Development to lead NMIBC- Excerpt from the Press Release: CARLSBAD, Calif., Jan. 10, 2025 /PRNewswire/ — Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that…
Read MorePDUFA target action date is June 30, 2025 If approved, avutometinib in combination with defactinib would be the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC cerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the…
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