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 ...

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

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has ...

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 ...

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...

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.

Aro Biotherapeutics, a clinical-stage biotechnology company working to develop potent and tissue-targeted medicines, today announced that it has received U.S. Food and Drug Administration (FDA) ...

These programmes are a beacon, offering routes to explore investigational drugs outside the typical confines of clinical trials. 2 They stand as lifelines for those who have journeyed through ...

This study will evaluate HCW9302 in patients with moderate to severe alopecia areataMIRAMAR, Fla., Feb. 03, 2025 (GLOBE ...

Ultragenyx Pharmaceutical RARE reported new findings from an ongoing, pivotal study of its investigational candidate, UX111 (ABO-102) AAV gene therapy, for Sanfilippo syndrome type A (MPS IIIA). Per ...

Animal-drug maker Zoetis ... side effects from a new arthritis injection that have caused some dogs to be euthanized. The company said Tuesday it updated the prescribing label of the drug, Librela ...