Tag: Drug Approvals
10 Percent of New Drugs Approved Without Meeting Primary Efficacy End Points
Findings seen for 21 drug approvals between 2018 and 2021, with only one-third needing postmarketing studies
FDA Approves New Drug for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
The next-generation BTK inhibitor zanubrutinib showed greater progression-free survival and fewer side effects in phase 3 trial
FDA Approves New Two-Drug Combo Medicine for Asthma
Medication is the first approved in the United States to contain an inhaled corticosteroid as a reliever rather than as a controller of asthma symptoms
FDA Approves Second Drug for Alzheimer Disease, Despite Safety Concerns
Approval of Leqembi comes after controversial approval in 2021 of Aduhelm, which met with criticism over concerns about that drug's effectiveness, safety, pricing
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
