FDA Approvals

Date Posted
Article Title
10/11/2019
FDA Approves Reyvow for Acute Migraine

In clinical trials, pain resolved at two hours in significantly more patients taking Reyvow versus placebo

10/9/2019
Implant Approved for Patients With Phototoxic Reactions From Rare Disorder

Scenesse increases pain-free light exposure in patients with erythropoietic protoporphyria

10/4/2019
FDA Approves Descovy for HIV-1 Preexposure Prophylaxis

Drug indicated to reduce risk for HIV-1 infection from sex excluding receptive vaginal sex

10/1/2019
Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases

Approval of Rituxan expanded to children with granulomatosis with polyangiitis, microscopic polyangiitis

9/30/2019
Mavyret Approved as 8-Week Treatment for Hep C, Compensated Cirrhosis

Drug approval expanded to any treatment-naive HCV patients, regardless of cirrhosis status or treatment type

9/26/2019
FDA Approves Vaccine for Prevention of Smallpox, Monkeypox

Jynneos is approved for adults considered at high risk for infection

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

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
New Antibiotic Approved for Community-Acquired Bacterial Pneumonia

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

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
Rozlytrek Approved to Treat Tumors With NTRK Gene Fusion

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

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

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

8/16/2019
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 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