Tag: Food & Drug Administration
FDA to Hold First Public Meeting on CBD
Scheduled speakers will include doctors, consumers, and cannabis industry members
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 Permits Marketing of Test to Detect Periprosthetic Joint Infection
Synovasure Lateral Flow Test Kit could help patients avoid unnecessary revision surgery
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
Avelumab + Axitinib Approved for Treatment of Renal Cell Carcinoma
Treatment combination demonstrated longer progression-free survival versus sunitinib in randomized trial
FDA Approves Venetoclax for Chronic, Small Lymphocytic Leukemia
In randomized trial, drug demonstrated statistically significant improvement in progression-free survival
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
