Food and Drug Administration News

Date Posted
Article Title
9/19/2019
9/16/2019
9/13/2019
9/13/2019
9/11/2019
9/11/2019
9/9/2019
FDA Approves First Treatment for ILD With Systemic Sclerosis, Scleroderma

Approval of Ofev for this indication based on data from SENSCIS study

9/9/2019
9/6/2019
9/5/2019
8/29/2019
8/28/2019
Nourianz Approved to Treat 'Off' Episodes in Parkinson Disease

Drug showed efficacy as add-on treatment for 'off' episodes in PD patients taking levodopa/carbidopa

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

8/15/2019
8/14/2019
Pretomanid Approved for Treatment of Drug-Resistant TB

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

8/8/2019
8/5/2019
8/2/2019
8/1/2019
7/31/2019
7/25/2019
7/24/2019
7/23/2019
7/18/2019
7/16/2019
7/10/2019
7/8/2019
6/28/2019
6/27/2019
6/25/2019
6/25/2019
6/24/2019
6/22/2019
6/18/2019
6/11/2019
6/11/2019
6/11/2019
6/11/2019
6/4/2019
5/31/2019
5/31/2019
5/20/2019
4/30/2019
4/29/2019
4/29/2019