FDA approval – Medxy AI

FDA Approval of Trastuzumab Deruxtecan: Advancing Treatment for HR-Positive HER2-Low and Ultralow Metastatic Breast Cancer

By MedXY 09/08/2025

Trastuzumab deruxtecan (T-DXd) gains FDA approval for HR-positive, HER2-low and HER2-ultralow unresectable or metastatic breast cancer after endocrine therapy progression, offering significant progression-free survival benefits over chemotherapy.

Clinical Updates Wellness & Lifestyle

FDA Approves Subcutaneous Lecanemab for Maintenance Treatment in Early Alzheimer’s Disease: A Step Toward More Accessible Care

By MedXY 09/02/2025

The FDA has approved a subcutaneous form of lecanemab for maintenance therapy in early Alzheimer’s, offering similar clinical benefits to IV dosing with improved convenience and safety, potentially transforming patient care delivery.

Clinical Updates Wellness & Lifestyle

FDA Approves Updated COVID-19 Vaccines Targeting Latest LP.8.1 Variant for High-Risk and Older Adults

By MedXY 08/31/2025

The FDA has authorized updated COVID-19 vaccines from Pfizer and Moderna designed to target the LP.8.1 sublineage, expanding vaccination to adults over 65 and individuals with high-risk conditions, enhancing immune defense against evolving variants.

Clinical Updates Wellness & Lifestyle

FDA Approves ArteraAI Prostate: The First AI-Driven Software Transforming Localized Prostate Cancer Management

By MedXY 08/19/2025

ArteraAI Prostate, the first FDA-approved AI-driven multimodal software, offers personalized clinical decision support for localized prostate cancer, improving treatment precision and reducing overtreatment risks.

Clinical Updates Wellness & Lifestyle

FDA Approves Tonmya: First Nonopioid Sublingual Treatment Targeting Sleep in Fibromyalgia

By MedXY 08/19/2025

The FDA has approved Tonmya (sublingual cyclobenzaprine) as the first new fibromyalgia therapy in 15 years, targeting nonrestorative sleep to alleviate pain, fatigue, and cognitive symptoms in adults.

Clinical Updates Wellness & Lifestyle

Alcon’s Tryptyr: A New Neuromodulatory Approach for Rapid Dry Eye Relief

By MedXY 08/02/2025

Alcon introduces Tryptyr, the first TRPM8 agonist eye drop, promising rapid tear production for dry eye disease. FDA-approved in May 2024 following robust phase 3 trials.

Clinical Updates Wellness & Lifestyle

FDA Approves Once-Daily Vizz (Aceclidine Ophthalmic Solution 1.44%) for Presbyopia: Clinical Implications and Evidence Review

By MedXY 08/02/2025

The FDA has approved Vizz, a once-daily aceclidine ophthalmic solution, for presbyopia in adults based on robust phase 3 data. The eye drop offers up to 10 hours of improved near vision with a favorable safety profile.

Clinical Updates Wellness & Lifestyle

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.