FDA – Medxy AI

The Dawn of the “No-Clinical-Trial” Era for Biosimilars: FDA’s Historic Ustekinumab Approval Shift

By MedXY 09/06/2025

The US FDA's unprecedented exemption of clinical efficacy studies for a ustekinumab biosimilar marks a transformative regulatory milestone, reshaping biosimilar development, market dynamics, and patient access worldwide.

Medical News Wellness & Lifestyle

CDC Retracts Universal COVID-19 Vaccination Recommendation for Pregnancy: Clinical Context, Evidence, and Implications

By MedXY 07/30/2025

The CDC no longer universally recommends COVID-19 vaccination during pregnancy, prompting debate among clinicians as the FDA shifts vaccine composition to target the JN.1 variant. This article analyzes the evidence, rationale, and clinical implications.

Clinical Updates Wellness & Lifestyle

FDA Fast-Tracks Rezpegaldesleukin for Severe Alopecia Areata: Promise for a Challenging Disease

By MedXY 07/30/2025

The FDA has granted Fast Track status to rezpegaldesleukin (REZPEG), a novel biologic targeting regulatory T cells, for severe-to-very severe alopecia areata in patients aged ≥12 years. Phase 2b trial results are anticipated in December 2025.

Wellness & Lifestyle

SSRIs and Pregnancy: Navigating the Risks, Benefits, and Ongoing Debate

By MedXY 07/29/2025

A new FDA panel reignites debate over the safety and efficacy of antidepressant use during pregnancy, with experts weighing in on emerging research and practice recommendations.

Wellness & Lifestyle

Rethinking Menopausal Hormone Therapy: Experts Urge FDA to Revise Outdated Warnings

By MedXY 07/29/2025

Leading experts call on the FDA to update boxed warnings on menopausal hormone therapies, arguing current labels are outdated and deter women from effective, safe treatments.

Wellness & Lifestyle

FDA Advances Treatment for Hypoactive Sexual Desire Disorder in Postmenopausal Women

By MedXY 07/29/2025

The FDA grants Priority Review to expand flibanserin use for treating low sexual desire in postmenopausal women, addressing an important gap in women's health.

Wellness & Lifestyle

FDA Extends Review of Bayer’s Elinzanetant for Menopause Symptoms

By MedXY 07/28/2025

The FDA delays its review of Bayer's elinzanetant, a novel treatment for menopause-related vasomotor symptoms, by 90 days, citing the need for additional data assessment.