FDA – Medxy AI

The Withdrawal of OCALIVA: Impact and Implications for Primary Biliary Cholangitis Treatment

By MedXY 09/21/2025

Intercept Pharmaceuticals withdraws OCALIVA from the US market following FDA demands due to safety concerns and lack of proven efficacy in PBC, prompting suspension of related clinical trials and significant shifts in therapeutic landscape.

Clinical Updates news Public Health Specialties

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 news Public Health Specialties

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 Dermatology news Specialties

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.

news OB/GYN & Women's Health Specialties

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.

news OB/GYN & Women's Health Specialties

Rethinking Menopausal Hormone Therapy: Experts Urge FDA to Revise Outdated Warnings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Leading experts call on the FDA to update boxed warnings on menopausal hormone therapies, arguing current labels are outdated and deter women from effective, safe treatments.

news OB/GYN & Women's Health Specialties

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.

news OB/GYN & Women's Health Specialties

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.