FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Extends Treosulfan NDA Review by 3 Months

[ Price : $8.95]

Medexus Pharmaceuticals says FDA has extended the review of its Medac licensors resubmitted NDA for treosulfan and its use in allo...

New Electronic Common Technical Document Version

[ Price : $8.95]

Federal Register notice: FDA announces its support for Electronic Common Technical Document Version 4.0 (v4.0)-based electronic su...

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...