Tag: Food & Drug Administration
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
FDA Takes Hard Look at CBD
CBD products have swamped the market due to change in federal law, not because of new medical evidence
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
