Otsuka Seeks Accelerated Approval for Sibeprenlimab in IgA Nephropathy Following Positive Phase III Interim Results

Otsuka, sibeprenlimab, IgA nephropathy, Phase III trial, accelerated approval, FDA, kidney disease, autoimmune disease, APRIL antibody.

Vertex’s Non-Opioid Pain Drug Suzetrigine Nears FDA Approval: A Breakthrough in Acute Pain Management

Suzetrigine, Non-opioid pain drug, Acute pain management, FDA approval, Vertex Pharmaceuticals, NaV1.8 pain signal inhibitor, Opioid epidemic, Pain relief without addiction risk

European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment

Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions

FDA Approves Vyalev: A Breakthrough Continuous Infusion Therapy for Advanced Parkinson’s Disease

Vyalev, Parkinson’s disease, continuous infusion therapy, FDA approval, AbbVie, motor fluctuations, levodopa, carbidopa