A Prescription Drug User Fee Act target date of July 27, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License ...

Sogroya is a long-acting form of somatropin. Somatropin is also called human growth hormone. Sogroya is made by attaching human growth hormone to a small protein that helps it stay in the body longer ...

Pfizer disclosed the regulatory action late Friday. FDA complete response letters are not public documents, and the company did not say what concerns or questions were raised by the agency about the ...

(Reuters) -The U.S. Food and Drug Administration has approved Pfizer Inc and partner OPKO Health Inc's treatment for growth hormone deficiency in children, the companies said on Wednesday. The ...

NEW YORK & MIAMI--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a ...

MISSION, Kan., June 16, 2025 /PRNewswire/ -- (Family Features) Pediatric growth hormone deficiency (GHD) is a relatively rare condition, affecting an estimated 1 in 4,000-10,000 children. Despite its ...

The FDA approved long-acting injectable somatrogon (Ngenla) for pediatric human growth hormone deficiency, developers Pfizer and OPKO Health announced this week. Somatrogon is indicated for children ...

The approval was based on data from the phase 3 heiGHt trial that assessed Skytrofa in 161 treatment-naïve, prepubertal patients with growth hormone deficiency. The Food and Drug Administration has ...

The once-weekly growth hormone analog somapacitan (Sogroya, Novo Nordisk) has been given the green light in both Europe and the United States for the treatment of children and adolescents with growth ...

Recent research findings put a spotlight on the link between human growth hormone (HGH) and Alzheimer’s disease. Could taking HGH increase your risk of Alzheimer’s? Ultimately, scientists say they ...