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 ...

Q: How can potential medication errors be minimized when dispensing investigational drugs ... preparing, and labeling of study drugs; and facilitate the transition to CPOE.

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 ...

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

Novo Nordisk’s NVO shares gained 8.5% on Friday after the company announced positive top-line data from an early to mid-stage ...

Gossamer Bio, Inc. , a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary ...

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 ...

February is observed as American Heart Month, a period dedicated to raising awareness about heart health. The first American Heart ...

The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid ...

Kiran Mazumdar-Shaw praises a new drug that can regrow human teeth. The drug was developed by Toregem Biopharma. It works by targeting and blocking USAG-1 protein. Researchers tested the drug ...

Corporation (NASDAQ: UTHR) has received clearance from the U.S. Food and Drug Administration (FDA) to begin a pioneering clinical trial of its gene-edited xenotransplantation kidney, named UKidney, ...