FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Rituxan Approved for Granulomatosis in Children

[ Price : $8.95]

FDA approves Genentechs Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in ch...

Galt Marketing Email Gets FDA Warning

[ Price : $8.95]

An email distribution by Galt Pharmaceuticals to health professionals draws an FDA Warning Letter on insomnia drug Doral (quazepam...

Abbott Recharge-Free Neurostimulation Device OKd

[ Price : $8.95]

FDA approves Abbotts Proclaim XR recharge-free neurostimulation system for people with chronic pain.

Meeting on ICH Clinical Trial Guide

[ Price : $8.95]

Federal Register notice: FDA announces a 10/31 public meeting on an International Council on Harmonization guideline on clinical t...

Digital Health Innovation Guidances Out

[ Price : $8.95]

FDA issues new and updated guidances to clarify regulatory oversight of various digital health tools.

Zogenix Resubmits Dravet Syndrome NDA

[ Price : $8.95]

Zogenix resubmits an NDA for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome.

Draft Guide on Device e-Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance on medical device regulatory electronic submissions.

CDER Reorganization Clears Congress

[ Price : $8.95]

CDER director Janet Woodcock says Congress has approved the Centers reorganization plan and it is being implemented.

Advisors Asked About Pediatric Singulair Neuropsych Events

[ Price : $8.95]

FDA asks members of two advisory committees for input on labeling options and communications strategies to address neuropsychiatri...

Janssen sBLA for Combination Darzalex Use in Myeloma

[ Price : $8.95]

FDA approves a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and ...