Industry Insight | FDA Adds Boxed Warning to Johnson & Johnson and Legend Biotech’s CAR-T Therapy Carvykti
October 10, 2025 — Washington, D.C. — The U.S. Food and Drug Administration (FDA) has issued a new safety update for Carvykti (ciltacabtagene autoleucel), a CAR-T cell therapy co-developed by Johnso...
More+
Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)” (No. 30, 2022)
In order to standardize and guide the pharmaceutical research and development, production and registration of immune cell therapy products, under the deployment of the National Medical Products Admini...
More+
Industry Insight | Experimental Gene Therapy Restores Immune Systems in Children with Deadly Disorder
An international research collaboration between UCLA, University College London (UCL), and Great Ormond Street Hospital has achieved a breakthrough in treating a fatal childhood immune disorder, adeno...
More+
Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022)
In order to standardize and guide the pharmaceutical research and development, production and registration of in vivo gene therapy products, under the deployment of the National Medical Products Admin...
More+
Industry Insight | McKesson Report: Cell and Gene Therapies Grow Rapidly, but Cost and Access Gaps Persist
October 2025 · Irving, Texas — McKesson Corporation, one of the world’s leading healthcare service and distribution companies, has released its latest industry report showing that while cell and ge...
More+
CDE issued “Guidelines on Clinical Trial Statistics of Drug Products for Rare Diseases (Interim)”
In order to encourage the development of drugs for rare diseases and guide applicants to improve R&D efficiency from the perspective of clinical research methodology, the Drug Evaluation Center or...
More+
Industry Insight | Eli Lilly Expands Gene Therapy Portfolio with $262 Million Acquisition of Adverum Biotechnologies
October 2025 — Indianapolis, IN / Redwood City, CA — Eli Lilly and Company announced the acquisition of Adverum Biotechnologies in a deal valued at up to USD 262 million, strengthening Lilly’s stra...
More+
Important Report from CDE! The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021)
In order to fully grasp the progress of clinical trials for new drug registration in China, use information technology to improve drug regulatory capabilities, and timely disclose clinical trial progr...
More+