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...
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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...
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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...
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MIT Researchers Develop Tunable Gene Expression System for Synthetic Biology and Therapeutic Applications
October 2025 — Cambridge, MA — A team of scientists at the Massachusetts Institute of Technology (MIT) has developed a new system that allows researchers to precisely dial up or down the expression ...
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CDE: Notification of Public Comment Soliciting on “Technical Guideline for the Clinical Research and Development of New Drug Products for Chronic Lymphocytic Leukemia (Draft for Comments)”
Chronic lymphocytic leukemia (CLL) is a mature B lymphocyte clonal proliferation tumor that mainly occurs in the middle-aged and elderly population. Its overall incidence rate is increasing due to the...
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UMass Chan Launches Global Gene and Cell Therapy Training Program to Advance HIV Cure Research
October 2025 · Worcester, Massachusetts — UMass Chan Medical School announced a five-year partnership with Makerere University and Mbarara University of Science and Technology in Uganda to strengthe...
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Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (October 2022)On October 13, 2022, the FDA (CDER and CBER) issued the...
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