FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Posts Laboratory-Developed Test FAQs

[ Price : $8.95]

FDA posts answers to frequently asked questions about its new laboratory-developed test final rule.

Merck Touts Clesrovimab Data in RSV

[ Price : $8.95]

Merck reports positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab in treating respira...

Group Outlines Considerations for OS Analyses

[ Price : $8.95]

Experts from FDA and two other groups publish considerations for the use of overall survival as an endpoint in cancer clinical tri...

Genentech sBLA for Susvimo Accepted for Review

[ Price : $8.95]

FDA accepts a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular ed...

Think Surgical Tmini Robot and Software Cleared

[ Price : $8.95]

FDA clears a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty pro...

Panel Input on Need for New Imfinzi Trial: FDA

[ Price : $8.95]

FDA plans to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental B...

Biosimilar Postapproval Manufacturing Change Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Ques...

FDA Corrects Xenpozyme Patent Notice

[ Price : $8.95]

Federal Register notice: FDA corrects a 7/2 notice that announced the determination of the regulatory review period for Sanofis Xe...

J&J Seeks Spravato as Monotherapy in Depression

[ Price : $8.95]

Johnson & Johnson seeks approval of Spravatos (esketamine) approval as monotherapy for adults living with treatment-resistant depr...

Samsung's Soliris Biosimilar Approved

[ Price : $8.95]

FDA approves a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexions Soliris (eculizumab), indicated for t...