Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney ...

The company has already kicked off an open-label Phase I trial of ABX1100 in Canada following positive results from a study of healthy volunteers.

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application ...

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

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 ...

Renalys Pharma completes patient enrollment in registrational phase III trial of sparsentan for IgA nephropathy in Japan: Tokyo, Japan Friday, January 31, 2025, 18:00 Hrs [IST] Re ...