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Human Drugs

FDA Will Review Eylea sBLA for an Extended Dosing Regimen

FDA sets 2/28/23 as the target date for its review of a Regeneron sBLA for a 167-week dosing regimen of Eylea in patients with diabetic retinopathy.

FDA General

Attorneys See Renewed DoJ Interest in Fraud-on-FDA

A Duane Morris legal alert says the Justice Department is showing a renewed interest in fraud-on-FDA cases.

Human Drugs

Improve FDA Foreign For-Cause Inspections: OIG

The HHS Inspector General says FDA agrees with its recommendations to improve foreign for-cause drug inspections.

Medical Devices

Invictus Sterilization Air Purifier Cleared

FDA clears an Invictus Sterilization 510(k) for the Aura Storm ultraviolet medical air purifier that is intended to inactivate bacteria and viruses (e...

Human Drugs

Santhera Pharma Delays NDA Over Inspection Readiness

Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy has been postponed by four to six months aft...

Human Drugs

100 Members of Congress Want HHS to Lower Drug Prices

Some 100 members of Congress call on HHS to use existing legal authorities to lower drug prices in the U.S.

Human Drugs

2 Drugs Have Positive Effect on Alzheimers Disease: Study

University of Colorado researchers say they have identified two FDA-approved drugs that may help prevent Alzheimers disease and improve cognition in A...

Federal Register

Guide on Renal Cell Carcinoma Drug Development

Federal Register notice: FDA makes available a final guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment....

Human Drugs

FDA Complete Response Letter for Spero NDA

An FDA complete response letter says a Spero Therapeutics NDA for tebipenem HBr tablets to treat adults with complicated urinary tract infections cann...

Biologics

Multiple Violations at Re-Gen Active Lab

FDA warns Irving, TX-based Re-Gen Active Lab about multiple violations in its production and marketing of several cellular-based drug products.