FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Subcutaneous Tecentriq Hybreza Approved

[ Price : $8.95]

FDA approves a subcutaneous injectable formulation of Genentechs Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for all t...

FDA Corrects ANDA Approval Withdrawals from 6/21

[ Price : $8.95]

Federal Register notice: FDA corrects a notice that appeared in the 6/21 Federal Register announcing the approval withdrawal 20 AN...

Expanded Approval for Dupixent in Rhinosinusitis

[ Price : $8.95]

FDA grants expanded approval for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for...

Lillys Ebglyss Approved for Eczema

[ Price : $8.95]

FDA approves an Eli Lilly BLA for Ebglyss (lebrikizumab-lbkz) for treating adults and children 12 years of age and older with mode...

FDA Clears SamanTrees Histolog Scanner

[ Price : $8.95]

FDA clears a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identi...

Genentechs Ocrevus Zunovo Approved for MS

[ Price : $8.95]

FDA approves Genentechs Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relap...

Senators Introduce Bill to Reduce Animal Testing

[ Price : $8.95]

A group of bipartisan U.S. senators introduce the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the ...

Feedback Sought on Integrated Review Document

[ Price : $8.95]

FDA seeks comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, ori...

FDA Publishes 8th Revision of Electronic Format Guide

[ Price : $8.95]

FDA publishes the eighth revision of a guidance on providing regulatory submissions for certain drug products in electronic format...

Apple AirPods Hearing Software Authorized

[ Price : $8.95]

FDA authorizes Apples Hearing Aid Feature software to use with compatible AirPods Pro headphones to operate as an over-the-counter...