FDA Related News

Medical Devices

FDA Reiterates Wingspan Stent Risk

FDA says using the Stryker Wingspan stent system on patients not meeting criteria in the approved indications for use increases the risk of stroke or ...

Medical Devices

Boston Scientific Aortic Valve Replacement OKd

FDA approves a Boston Scientific PMA for the LOTUS Edge Aortic Valve System.

FDA General

NIH Streamlines Gene Therapy Oversight

The NIH works with FDA to modify government oversight of gene therapy.

Medical Devices

Non-Clinical Bench Performance Content Guidance

FDA publishes a guidance on the content and f.ormat of non-clinical bench performance testing information in premarket submissions.

Medical Devices

Final Guide on UDI Convenience Kit Labeling

FDA releases a final guidance on Unique Device Identification: Convenience Kits.

Human Drugs

Gilead Selonsertib Trial Misses Endpoint

Gilead Sciences says its Phase 3 STELLAR-3 study, which evaluated selonsertib in patients with bridging fibrosis due to nonalcoholic steatohepatitis, ...

Human Drugs

Ortho Dermatologics Gain Psoriasis Lotion Approval

FDA approves an Ortho Dermatologics NDA for Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, indicated for the topical treatment ...

Astellas, Amgen Settle Kickback Charges for $125 Million

The Justice Department says Astellas and Amgen will pay a total of $124.75 million to resolve charge that they paid illegal kickbacks to patients to u...

Human Drugs

Lilly Yanks Cancer Drug Lartruvo from Market

Eli Lilly says it is withdrawing rare cancer drug Lartruvo (olaratumab) from the market based on data from a confirmatory trial in which the drug did ...

Medical Devices

2 Former Arriva Execs Settling False Claims Act Charges

The Justice Department says two former Arriva executives are paying $500,000 each to resolve False Claims Act cases against them involving Medicare cl...