Announcement on Obtaining Orphan Drug Designation from the U.S. FDA
August 7, 2025
Source: drugdu
85
On the evening of August 6, Hengrui MedicineThe company recently received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its Ruikang trastuzumab injection, combined with adebelimumab injection and chemotherapy, for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma. Orphan drugs, also known as rare disease drugs, are used to prevent, treat, or diagnose rare diseases. This FDA orphan drug designation provides the company with opportunities to benefit from U.S. policy support in product development, registration, and commercialization.
https://finance.eastmoney.com/a/202508063477857963.html
By editor
Copyright©2025 Ddu. All rights reserved.
Read more on
- The application for marketing authorization of trivalent influenza virus split vaccine has been accepted October 8, 2025
- Walvax Biopharma’s vaccine receives Jordanian Drug Registration Certificate, marking a key step forward in its Middle East market expansion. October 8, 2025
- Zhifei Bio’s independent product, influenza virus split vaccine, has obtained a drug registration certificate October 8, 2025
- Antihypertensive and lipid-lowering drugs show efficacy against steatotic liver disease October 7, 2025
- Large-scale analysis offers insights into sporadic nature of chikungunya virus outbreaks October 7, 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.
