FDA approval - Medxy AI

FDA Approves Linzess for Pediatric IBS with Constipation: A New Hope for Children

By MedXY 11/06/2025

The FDA has approved linaclotide (Linzess) for treating irritable bowel syndrome with constipation (IBS-C) in children 7 and older, marking the first official treatment option for pediatric IBS-C.

news Ophthalmology Pediatrics

Understanding the FDA’s Rejection of SYD-101: Navigating the Challenges in Pediatric Myopia Treatment

By MedXY 11/04/2025

The FDA has rejected Sydnexis's low-dose atropine eye drop SYD-101 for controlling childhood myopia progression despite promising trial results, highlighting challenges in demonstrating long-term efficacy and clinical significance in new pediatric myopia therapies.

Nephrology news Rheumatology

FDA Approves Roche’s Obinutuzumab for Lupus Nephritis: Promising Advances in B-cell Targeted Therapy

By MedXY 10/24/2025

The FDA has approved Roche’s obinutuzumab for active lupus nephritis in adults, offering a twice-yearly dosing regimen that achieved nearly 50% complete renal remission in trials, marking a significant advancement in lupus nephritis management.

AI Clinical Updates news Specialties

Evaluating the Clinical Generalizability of FDA-Approved AI-Enabled Medical Devices: Insights and Implications

By MedXY 09/28/2025

A comprehensive analysis of 903 FDA-approved AI medical devices reveals limited clinical performance data and demographic inclusivity, underscoring the need for ongoing evaluation to ensure safe, effective clinical application.

Clinical Updates news Oncology

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.

Neurology Specialties

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.

Public Health Specialties

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 news

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.

Neurology news Specialties

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 news Ophthalmology Specialties

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 news Ophthalmology Specialties

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 Diabetes & Endocrinology news Specialties

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.

HIV/AIDS Medical News news Public Health Specialties

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.

Internal Medicine Medical News Pediatrics Specialties

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 news Pediatrics Specialties

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.