△ A grand contribution, 1 main forum, 5 sub-forums, 9 thematic forums, hundreds of industry leaders, many renowned clinical PIs and dozens of CMOs gathered, a thousand-person conference awaits you! ▼ Antibody-drug conjugates (ADCs) are currently developing rapidly, utilizing antibodies to selectively deliver cytotoxic drugs to tumor sites. As of May 2021, the U.S. Food … Read more
The U.S. Food and Drug Administration (FDA) launched its first agency-level generative AI assistant, Elsa, in June 2025. Aimed at all 18,000 employees (scientific reviewers, compliance investigators, policymakers, etc.), this tool marks a significant step in the FDA’s digital transformation, aiming to enhance review efficiency, reduce repetitive paperwork, and accelerate the review process for drugs … Read more
Source: MedRobot; Edited by: Tang Zijie Reprint Requirements: Can be reprinted 24 hours after the first release, with source acknowledgment This article reviews five orthopedic navigation and surgical robot products that received approval from the U.S. Food and Drug Administration (FDA) from January 2022 to the end of August, from three American companies: Surgalign (NASDAQ: … Read more
So far, more than 10 types of antibody-drug conjugates (ADC) have been approved by the U.S. Food and Drug Administration (FDA) and have contributed to the medical field. Interestingly, they are all manufactured using chemical conjugation techniques. This indicates that chemical conjugation is the primary method for ADC manufacturing. Compared to other conjugation techniques such … Read more
With the intelligence and informatization of medical devices, many off-the-shelf software (OTS) are being applied in medical devices. On August 11, 2023, the FDA released the Guidance for Industry and Food and Drug Administration Staff on Off-The-Shelf Software Use in Medical Devices, which aims to provide information that applicants should include in the documentation submitted … Read more