SAN DIEGO, Calif. – Of the 46 cancer drugs that the U.S. Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study...
treatment News
CHICAGO, Illinois – The American Society for Transplantation and Cellular Therapy® (ASTCT®) supports the decision by the U.S. Food and Drug Administration’s (FDA) to grant multiple myeloma patients earlier access to CAR T-cell therapy Abecma as a second-line treatment and the CAR T therapy Carvykti as a third-line treatment. The...
CHENGDU, China — On November 25, 2025, Clinical study results from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, HKEX: 6990)’s TROP2 ADC sacituzumab tirumotecan (sac-TMT) monotherapy for advanced or metastatic urothelial carcinoma (UC) patients has been published in the journal of Annals of Oncology (Impact Factor: 65.4). This study provides the first evidence of sac-TMT’s...
BOSTON, Mass. — The Barth Syndrome Foundation (BSF), the only patient advocacy organization dedicated to Barth syndrome and saving lives around the world through education, advances in treatment and finding a cure, today announced that it is petitioning the U.S. Food and Drug Administration (FDA) to review the New Drug...
PLEASANTON, Calif. & NANJING, China – IASO Biotherapeutics (IASO Bio) and Innovent Biologics, Inc. (Innovent, HKEX: 01801), today jointly announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for CT103A, an investigational chimeric antigen receptor (CAR)-T cell therapy...
WILMINGTON, Del. — Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard of care in previously untreated adult patients with...
Cambridge, UK – A combination of two drugs could improve outcomes and reduce the need for toxic chemotherapy for B-cell acute lymphoblastic leukemia (B-ALL), the commonest cancer in childhood and one that can be particularly difficult to treat in older patients, according to Cambridge scientists. Although the research has so...
Madrid, Spain – A few years ago, a patient was cured of multiple myeloma after being treated for hepatitis C, astounding researchers from the group led by Joaquín Martínez, from the H12O-CNIO Haematological Tumours Clinical Research Unit, a collaboration between the Hospital 12 de Octubre (H12O) and the National Cancer...
The cohort of 7000 rare diseases is complex, heterogeneous and dynamic. Newer conditions are being identified and reported regularly in the medical literature on a day to day basis. For a long time, the medical fraternity, researchers, and policymakers were unaware of the wide spectrum of rare diseases and the...
MONTREAL, Québec – Neurenati Therapeutics Inc., a biotechnology company dedicated to developing transformative therapies for rare pediatric diseases, is pleased to announce that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to NEU-001, a novel combination therapy leveraging a neurotrophic growth factor for the treatment of Hirschsprung...