FDA Approvals

Date Posted
Article Title
8/19/2019
Rozlytrek Approved to Treat Tumors With NTRK Gene Fusion

Drug also approved to treat metastatic non-small cell lung cancer with ROS1-positive tumors

8/19/2019
Implant Approved to Improve Symptoms in Advanced Heart Failure

Barostim Neo System indicated for patients not suited for cardiac resynchronization therapy

8/19/2019
New Antibiotic Approved for Community-Acquired Bacterial Pneumonia

Clinical data show similar results between Xenleta and moxifloxacin with or without linezolid

8/16/2019
Transcatheter Heart Valves Approved for Use in Low-Risk Patients

Approval expanded to patients with severe aortic valve stenosis at low risk for death, major complications

8/16/2019
FDA Approves Tether Device to Correct Idiopathic Scoliosis

Device provides alternative to fusion surgery when idiopathic scoliosis not responsive to bracing

8/16/2019
FDA Approves Inrebic Capsules for Myelofibrosis

Drug approved to treat adults with intermediate-2 or high-risk primary or secondary myelofibrosis

8/14/2019
Pretomanid Approved for Treatment of Drug-Resistant TB

Tablets approved with bedaquiline and linezolid for highly treatment-resistant pulmonary tuberculosis

8/5/2019
7/23/2019
7/18/2019
7/10/2019
6/28/2019
6/24/2019
6/18/2019
6/11/2019
6/11/2019
6/11/2019
6/11/2019
5/31/2019
5/28/2019
First PI3K Inhibitor Approved for Metastatic, Advanced Breast Cancer

Piqray approved for HR-positive, HER2-negative, PIK3CA-mutated, metastatic or advanced breast cancer