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FDA Approves Drug Combo for Metastatic Non-Small Cell Lung Cancer

Approval is for tremelimumab in combination with durvalumab and platinum-based chemotherapy

FDA Approves SPEVIGO for Generalized Pustular Psoriasis Flares

The monoclonal antibody infusion is approved for use in adults

FDA Approves First Treatment for Acid Sphingomyelinase Deficiency

The enzyme replacement therapy is administered through an intravenous infusion and approved for both adult and pediatric patients

FDA Approves Imbruvica for Pediatric Chronic Graft Versus Host Disease

Approval is for chronic disease after failure of one or more lines of systemic therapy

Tabrecta Gains Full FDA Approval for Non-Small Cell Lung Cancer

Drug approved for non-small cell lung cancer with mutation leading to MET exon 14 skipping

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

HER2-low is a new classification for a subset of HER2-negative breast cancer

FDA Approves Skyrizi for Moderately to Severely Active Crohn Disease

Skyrizi is first specific interleukin-23 approved to treat Crohn disease

New Cancer Drugs Approved Faster in U.S. Than Europe

FDA received licensing applications sooner and had shorter review times, compared to the European Medicines Agency

FDA Approves First Pill to Treat Severe Alopecia Areata

Olumiant is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot

Increased Flexibility Seen in Preapproval Evidence for New Drugs

Twenty-eight percent of trials used historical, external, or other control; nearly half used surrogate measure as a primary end point