Tag: Drug Approvals
First Anticoagulant Approved for Preventing VTE Recurrence in Children
Boxed warning lists risk for epidural, spinal hematomas with neuraxial anesthesia, spinal puncture
FDA Approves Venetoclax for Chronic, Small Lymphocytic Leukemia
In randomized trial, drug demonstrated statistically significant improvement in progression-free survival
Avelumab + Axitinib Approved for Treatment of Renal Cell Carcinoma
Treatment combination demonstrated longer progression-free survival versus sunitinib in randomized trial
FDA Approves Ruzurgi for Children With Rare Autoimmune Disorder
Ruzurgi previously approved for treatment in adults with Lambert-Eaton myasthenic syndrome
FDA Approves Treatments for Heart Failure Caused by Rare Disease
Capsules approved to treat cardiomyopathy caused by transthyretin mediated amyloidosis
FDA Approves Dengue Vaccine for Endemic Regions
Vaccine indicated for individuals aged 9 to 16 who have previously had laboratory-confirmed dengue disease
FDA Approves Mavyret for Children, Adolescents With Hep C
Drug approved for treatment of all six genotypes of hepatitis C virus in children ages 12 to 17
FDA Approves First Treatment for Pediatric Lupus
Approval based on study showing children who received Benlysta plus standard therapy had lower risk for flare
FDA Approves Pembrolizumab Plus Axitinib for Advanced RCC
Drug combination approved for advanced renal cell carcinoma based on findings from KEYNOTE-426
FDA Approves First Generic Nasal Spray Against Opioid Overdose
Product is also first generic naloxone nasal spray approved for use by people without medical training
