Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.

Granting patents to US firm Gilead Sciences for lenacapavir could hinder global efforts to end AIDS & restrict access to ...

adaptive behavior and tremor” and went ahead with filing a new drug application with the FDA. Applied had planned to ask for U.S. approval on the strength of biomarker data, only for the FDA to ...

Sankalp, a civil society organisation working with populations vulnerable to HIV, opposed the patent applications stating ... According to UNAIDS, this new HIV drug can offer hope of ending ...

Purpose: The revised prescription drug labeling ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug ...

Developing advanced drug screening tools is crucial for the advancement of personalized medicine and the creation of more effective treatments. One organ receiving particular attention in this area is ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

While the agency originally said the data were insufficient to support a new drug application, Clene has since submitted more information, including mechanistic and ALS-specific biomarkers and data on ...

Eleven researchers across multiple disciplines of health science research have been awarded funding in the Health Research ...

We believe that AI should serve people by improving efficiency and quality of life. AI can enable the digital transformation ...