Tag: Drug Approvals
FDA Expands Cystic Fibrosis Treatment Approval to Children Ages 6 to 12
Symdeko previously approved for patients ≥12 years with cystic fibrosis and certain genetic mutations
FDA Approves Victoza Injection for Children 10 Years and Older
~64 percent of children treated with Victoza achieved HbA1c levels less than 7 percent
Chemoimmunotherapy Regimen Approved to Treat DLBCL
Polivy approved in combination with bendamustine, rituximab for diffuse large B-cell lymphoma
Emgality Receives First FDA Approval for Treating Cluster Headache
Patients treated with Emgality had 8.7 fewer cluster headache attacks at 3.0 weeks versus 5.2 with placebo
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
