Tag: Drug Approvals
FDA Approves Sunlenca for Treatment-Resistant HIV
Sunlenca is the first capsid inhibitor approved for HIV
FDA Approves Gene Therapy for Tough-to-Treat Bladder Cancer
About 57,000 men and 18,000 women are diagnosed with bladder cancer annually
FDA Approves First Gene Therapy for Adults With Hemophilia B
Benefits include decreased need for routine factor IX replacement prophylaxis and reduction in annualized bleeding rate
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
