media – Page 11 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

FDA Limits Duchenne Gene Therapy After Two Teens Die of Liver Failure

MONDAY, Nov. 17, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is tightening restrictions on a gene therapy used to treat Duchenne muscular dystrophy after two teenagers died from liver failure linked to the medication. The FDA decision limits the use of Elevidys, made by Sarepta Therapeutics, to boys who are 4 years and older who can still walk, the agency said. It will no longer be allowed for boys who have already lost mobility, something that typically happens around age 12 for patients with Duchenne. Officials said a safety review confirmed that the two teens developed severe liver damage after receiving the infusion. Both later died. The FDA is also adding its strictest boxed warning to highlight the risks of serious liver injury, acute liver failure and death. Sarepta, based in Cambridge, Massachusetts with offices worldwide, told regulators earlier this year that it had already stopped ...
- Source: drugdu
- 58
- November 18, 2025
Nine drugs, including HRS-4642 injection, received approval notices for clinical trials.

　　Nanfang Finance News, November 17th – Jiangsu Hengrui Medicine Co., Ltd. ( 01276.HK) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd., recently received approvals from the National Medical Products Administration for HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, adebecilimab injection, bevacizumab injection, SHR-A2102 for injection, and apple .The Clinical Trial Approval Notices for Famitinib Malate Capsules and Dalcilide Ethylhex … https://finance.eastmoney.com/a/202511173566406150.html
- Source: drugdu
- 73
- November 18, 2025
China’s First FRα-ADC Drug Receives Routine Approval

　　On the evening of November 17th, Huadong Medicine(000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its supplemental application to change from conditional approval to regular approval for somituximab injection (ELAHERE®). 　　The announcement indicates that somituximab is the first and currently only FRα-targeting ADC drug approved in China, the United States, and the European Union for the treatment of platinum-resistant ovarian cancer (PROC). Hangzhou Sino-American East China Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, holds exclusive clinical development and commercialization rights for this product in Greater China. 　　It is understood that somituximab is an innovative ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer), developed in collaboration between Sino-American Huadong and Immuno Gen, Inc. (now acquired by AbbVie).It consists of an FRα-binding antibody, a cleavable linker, ...
- Source: drugdu
- 77
- November 18, 2025
Former Hengrui Medicine executive Shen Yaping joins Hanyu Pharmaceutical, marking the beginning of a new journey for the company’s international development.

　　On November 17th, Hanyu Pharmaceutical, a leading company in peptide drugs…(300199.SZ) announced a major personnel appointment: former Hengrui MedicineMr. Shen Yaping, Vice President and Head of International Business, has officially assumed the position of Executive President of Hanyu Pharmaceutical . 　　The announcement states that Dr. Shen Yaping graduated from the University of Ottawa, Canada, and previously worked for several well-known overseas pharmaceutical companies, including Inflazyme (Canada), Lipont (USA), and Chemwerth (USA). He joined Hengrui Medicine in 2012 , serving successively as Assistant to the Chairman and Vice President, overseeing Hengrui Medicine’s International Business Department, International Generic Drug Research Institute, eVenus (USA), Hengrui (Japan), and Hengrui (Singapore), responsible for APIs, generic drugs, and some innovative drugs.Market development, registration, sales, and maintenance of products in overseas markets. 　　His joining not only signifies a proactive choice regarding the development of Hanyu Pharmaceutical’s peptide field and its international commercial prospects after in-depth analysis of ...
- Source: drugdu
- 73
- November 18, 2025
Iza-bren met its primary endpoint in interim analysis of a phase III clinical trial for recurrent or metastatic esophageal squamous cell carcinoma.

　　Baili Tianheng(688506) announced on the morning of November 18th that its independently developed, world’s first, novel, and only EGFR×HER3 bispecific antibody ADC (iza-bren) to enter Phase III clinical trials for esophageal squamous cell carcinoma has met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in the pre-specified interim analysis, as determined by the independent data monitoring committee. The indication is recurrent or metastatic esophageal squamous cell carcinoma that has failed prior treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. This is the world’s first Phase III clinical study of an ADC drug to achieve double positive results for PFS/OS in the treatment of esophageal cancer. https://finance.eastmoney.com/a/202511183566910923.html
- Source: drugdu
- 70
- November 18, 2025
KIHE 2026

Organiser：ITE Group, UK Time：May 20 – May 22, 2026 Address：42 Timiryazev str., Almaty, 050057 Almaty, Kazakhstan Exhibition hall：Atakent International Exhibition Centre Product range: Medical Equipment: Medical technology equipment, laboratory instruments and equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, first-aid and emergency equipment, hospital, dental, and medical equipment, dental service equipment and disposable medical products, disposable medical products for hospitals and households, hospital and dental data processing systems, dental orthopedic and rehabilitation equipment Pharmaceuticals: Foreign prescription drugs, herbal preparations, nutritional health products such as mineral and vitamin supplements, dietary nutritional products, homeopathic preparations, dermatological preparations, maternal and infant medical care products and baby food, personal hygiene products, incontinence products, medical consumables, cosmetics Pharmaceutical Industry: Equipment and technology for drug production, drug packaging equipment, drug packaging materials, drug production, cleaning, disinfection, and dispensing systems, raw materials and ingredients for the pharmaceutical industry, intermediates, pharmaceutical ...
- Source: drugdu
- 103
- November 18, 2025
【EXPERT Q&A】How long is the validity period of the ce certification certificate?

Drugdu.com expert’s response: The validity period of a CE certification certificate typically ranges from 1 to 10 years, with the specific duration depending on factors such as the product’s risk level, regulatory updates, and design modifications. Below is a detailed summary of the validity period of CE certification certificates: I. Validity Period Based on Product Risk Level Low-Risk Products: For products such as ordinary toys and general machinery, CE certificates usually have a validity period of 5 years. These products have relatively stable technical standards and lower safety risks, prompting certification bodies to issue long-term valid certificates. Medium-Risk Products: For products like construction products and personal protective equipment, CE certificates generally have a validity period of 3 years. These products require regular reviews of design documentation and production consistency to ensure compliance with new EU standards. High-Risk Products: For products such as implantable medical devices, dangerous machinery, boilers, pressure vessels, ...
- Source: drugdu
- 108
- November 17, 2025
Voluntary Information Disclosure Announcement Regarding the Company Obtaining Approval Notice for Drug Clinical Trials

　　SecuritiesDaily News reported on the evening of November 12th that Panlong Pharmaceutical…The company announced that it recently received a “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, approving the clinical trial of Panlongqi Gel Patch for knee osteoarthritis. https://finance.eastmoney.com/a/202511123562395262.html
- Source: drugdu
- 79
- November 15, 2025
Quanxin Bio-B Long-Acting Bispecific Antibody QX027N Injection Receives Approval for Two Clinical Trials

　　On November 13, Quanxin Bio-B (02509) issued an announcement stating that its independently developed long-acting bispecific antibody QX027N injection has obtained implied approval for clinical trials from the Center for Drug Evaluation of the National Medical Products Administration, with acceptance numbers CXSL2500757 and CXSL2500758. 　　This drug is intended for the treatment of asthma and atopic dermatitis, marking the official entry of the company’s innovative dual-antibody matrix in the field of autoimmune and allergic diseases into the clinical stage. https://finance.eastmoney.com/a/202511143564486287.html
- Source: drugdu
- 96
- November 15, 2025
Receives Approval Notice for New Clinical Trial of Innovative Drug HSK39297 Tablets

　　Haisco On November 13, the company announced that its HSK39297 tablets had received a “Drug Clinical Trial Approval Notice” from the National Medical Products Administration, approving the company to conduct clinical trials. The indication is age-related macular degeneration. https://finance.eastmoney.com/a/202511133563521296.html
- Source: drugdu
- 77
- November 15, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.