FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Rigel Pharma NDA for Fostamatinib

Rigel Pharmaceuticals files an NDA for fostamatinib in patients with chronic and persistent immune thrombocytopenia.

Human Drugs

St. Jude Medical Inspections Form-483 Released

FDA releases a Form-483 from a 2/7-17 inspection at Abbotts St. Jude Medical manufacturing facility in Sylmar, CA, that found Quality System Regulatio...

Federal Register

Pharmacy Compounding Advisory Committee Meeting 5/8-9

Federal Register notice: FDA announces a 5/8-9 Pharmacy Compounding Advisory Committee meeting that will hearing compounding updates and discuss addin...

Human Drugs

OncoMed Study Fails in Lung Cancer

OncoMed Pharmaceuticals says results from a Phase 2 trial evaluating tarextumab failed to meet its primary endpoint (progression free survival) or sec...

Human Drugs

FDA Approves Genentechs Lucentis for All Diabetic Retinopathy

FDA approves Genentechs Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy.

FDA General

Latest Federal Register Notices

FDA Review posts the latest Federal Register notices for the week ending 4/14/2017.

Human Drugs

House, Senate Release Draft Legislation to Renew User Fees

In a move to avoid layoff notices sent to FDA staff working under the agencys user fee programs, Senate and House health committee leaders release a b...

Human Drugs

Standard Homeopathic Recalls Hyland Teething Tablets

Standard Homeopathic recalls all lots of Hylands Baby Teething Tablets and Hylands Baby Nighttime Teething Tablets sold in retail stores.

Human Drugs

Lilly, Incyte Disagree with FDA Rejection on Arthritis Drug

Eli Lilly and Incyte disagree with an FDA complete response letter requesting additional data for their NDA for baricitinib, a once-daily oral medicat...

Medical Devices

FDA Clears EnsoData Sleep Monitoring Software

FDA clears an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals ...