The Phase I trial will evaluate the safety and efficacy of the company’s drug which targets tumours whilst leaving normal ...

and was personally in charge of approving new drugs and labeling changes within the FDA’s Center of Drug Evaluation and Research (CDER). Prior to that, Dr. Gortler served as an investigational ...

The last decade has seen a “dramatic increase” in investigational new drug (IND) applications for cannabis-derived products, according to the U.S. Food and Drug Administration. In a paper ...

The Shanghai-based firm will test the gene therapy candidate in patients between 4 and 9 years old with Duchenne muscular dystrophy.

(SLDB), Tuesday announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND ... initiate a first-in-human, open-label, dose-finding Phase 1b clinical ...