Tag: Drug Approvals
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
