FDA approval – Medxy AI

FDA Approves Once-Weekly Skytrofa (Lonapegsomatropin-tcgd) for Adult Growth Hormone Deficiency: Clinical Implications and Evidence Review

By MedXY 07/31/2025

Skytrofa, a once-weekly injectable growth hormone, is FDA-approved for adult GHD, offering improved adherence and positive metabolic outcomes. Clinical trials show superior efficacy and favorable safety compared to daily somatropin.

Medical News Wellness & Lifestyle

FDA Approves Lenacapavir: A Twice-Yearly Injectable PrEP Transforming HIV Prevention

By MedXY 07/31/2025

Lenacapavir (Yeztugo) becomes the first FDA-approved, twice-yearly injectable PrEP, offering robust long-acting HIV prevention and addressing key adherence barriers.

Medical News

FDA Approves Sephience: A New Oral Therapy for Phenylketonuria

By MedXY 07/30/2025

The FDA has approved Sephience, an oral therapy for phenylketonuria (PKU), offering a novel treatment option for both children and adults with this rare metabolic disorder.

Clinical Updates Wellness & Lifestyle

FDA Expands Skytrofa Approval to Adults with Growth Hormone Deficiency: Clinical and Practice Implications

By MedXY 07/30/2025

Once-weekly lonapegsomatropin (Skytrofa) is now FDA-approved for adult growth hormone deficiency, offering a more convenient alternative to daily injections with demonstrated efficacy and safety.