FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Eye Disease Gene Therapy Misses Endpoint: J&J

[ Price : $8.95]

Johnson & Johnson says its gene therapy botaretigene sparoparvovec missed the primary endpoint in the Phase 3 LUMEOS study that is...

Drug Spending Accelerated Last Year: Report

[ Price : $8.95]

A new report from IQVIA finds drug spending in 2024 accelerated, with net prices growing at an 11.4% rate last year compared with ...

FDA Withdraws and Reissues 2 Guidances

[ Price : $8.95]

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form to add c...

Petition Seeks to Restrict Da Vinci Off-Label Use

[ Price : $8.95]

A citizen petition asks FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy devices t...

FDA Rejects CytoSorbents Bleed Reducing Device

[ Price : $8.95]

FDA denies a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, intended for reducing the ...

MR Contour DL Model Cleared for Organ Segmentation

[ Price : $8.95]

FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-ri...

Agency Accepts Oral Wegovy NDA for Obesity

[ Price : $8.95]

FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight man...

FDA Rehiring Freedom of Information Staff

[ Price : $8.95]

FDA rehires some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts.

Vanda Tradipitant Scheduling Order Out

[ Price : $8.95]

The FDA Office of Scientific Integrity publishes a scheduling order for Vandas request for a hearing on a proposed CDER order to d...

FDA Rehiring Some Travel Support Staff

[ Price : $8.95]

The Associated Press reports FDA is attempting to rehire some travel support, food scientist, and Freedom of Information Act staff...