Tag: Drug Approvals
Zerbaxa Approved for Hospital-Acquired Bacterial Pneumonia
Drug previously approved for treatment of complicated intra-abdominal infections, UTIs
First PI3K Inhibitor Approved for Metastatic, Advanced Breast Cancer
Piqray approved for HR-positive, HER2-negative, PIK3CA-mutated, metastatic or advanced breast cancer
FDA Approves First Gene Therapy for Spinal Muscular Atrophy
Patients treated with Zolgensma have shown improvement in reaching developmental motor milestones
FDA Approves Venetoclax for Chronic Lymphocytic Leukemia
In randomized trial, drug demonstrated statistically significant improvement in progression-free survival
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
