Tag: Drug Approvals
FDA Approves First Treatment for Rett Syndrome
Approval of Daybue applies to adults and children aged 2 years and older
New Nasal Spray for Migraines Approved by FDA
About 40 percent of trial participants who took the medication were free of their worst symptoms two hours after using the medication
FDA Approves First Home Test to Detect Both Flu and COVID-19
Test will be sold without a prescription and can be used by anyone 14 years and older or by an adult on children ages 2 years and older
FDA Approves First Treatment for Geographic Atrophy
Pegcetacoplan approved as an injection with dosing every 25 to 60 days
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
