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Drug-Induced Liver Injury (DILI) remains a pivotal challenge in drug development, with evolving drug modalities and clinical trial designs prompting updated regulatory perspectives from FDA specialists.
The American College of Physicians urges Congress and regulators to modernize DSHEA, require premarket FDA review, strengthen surveillance, standardize labeling, and improve clinician tools to protect the public from unsafe or misleading di
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.
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.
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
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 202
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.
Leading experts call on the FDA to update boxed warnings on menopausal hormone therapies, arguing current labels are outdated and deter women from effective, safe treatments.
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.
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.