BOSTON, Oct. 13, 2025 -- General Oncology, Inc. (“General Oncology” or the “Company”), a clinical-stage biopharmaceutical company dedicated to pioneering first-in-class medicines for metastatic cancers, today announced that it will deliver a poster presentation featuring preliminary results from its ongoing Phase 1 SHARON trial (NCT04150042) evaluating GO-4: the Company’s patented Advanced Redox Modulation regimen consisting of melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous st

Oct. 13, 2025 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that preclinical efficacy of its highly selective CDK9 inhibitor, SLS009 (tambiciclib), as a monotherapy and in combination with venetoclax in T-cell prolymphocytic leukemia (T-PLL), will be presented at the European Society for Medical Oncology (ESMO)

Oct. 13, 2025 -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the U.S. Food and Drug Administration (FDA) Rare Disease Endpoint Advancement (RDEA) Pilot Program. The RDEA program facilitates the development and timely approval of rare disease therapies by supporting the use of novel e

Oct. 13, 2025 -- Hinge Bio, Inc., a privately-held biotechnology company engaged in the discovery and development of innovative multi-specific medicines, announced the U.S. Food and Drug Administration (“FDA”) has cleared the company’s Investigational New Drug (“IND”) application to initiate a study of HB2198 in patients with the B cell-mediated autoimmune diseases Systemic Lupus Erythematosus (“SLE”) and Lupus Nephritis (“LN”). “This IND clearance marks a significant milestone for Hinge Bio

October 9, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Biomedica for the distribution of AGAMREE® (vamorolone) in Russia, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. Under the terms of the agreement, Santhera will receive a percentage of net sales, in line with previous distribution agreements, with sales expected to begin in Q1 2026. This collaboration will enable access to AGAMREE for DMD

根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对人纤维蛋白原说明书内容进行统一修订。现将有关事项公告如下： 一、所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按要求修订说明书（见附件），于2026年1月10日前报省级药品监督管理部门备案。 修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换，或者以其他适当形式将更新信息告知患者。 二、 药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师或者患者合理用药。 三、 临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。 四、 患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。 五、 省级药品监督管理部门应当督促行政区域内上述药品的上市许可持有人，按要求做好相应说明书修订和标签、说明书更换及说明书更新信

Oct. 13, 2025 -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that complete data from the Phase 2b trial of rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis (RA), was accepted for a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, Oct. 24 – 29, 2025. “We are honored to be selected by ACR to present our late-breaking Pha

Oct. 13, 2025 -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma

Presentation will cover two-year clinical efficacy, immunogenicity and safety data Data will be presented at an oral session on October 17, 2025, followed by a webinar on October 22, 2025, providing further insights into the clinical findings October 13, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present a wide range of data from its phase 2 trial with lead compound EVX-01 at the European Socie

Oral presentation by Dr Zan highlighted novel Phase 1/2 SANTANA-225 study design of 225Ac-SSO110 in patients with ES-SCLC or MCC 225Ac-SSO110 achieves superior pharmacokinetics with minimal re-distribution of Actinium-225 daughter isotopes and 100% survival in preclinical studies Initial safety data from SANTANA-225 expected in 2026 Oct. 09, 2025 -- Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, today highlighted two or