FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Viking Reports Mixed Data on Obesity Drug

[ Price : $8.95]

Viking Therapeutics reports mixed data from a Phase 2 study for its oral obesity drug VK2735, with patients losing up to 12.2% of ...

AI-DSF Change Control Plan Guidance

[ Price : $8.95]

FDA publishes a guidance with recommendations on the information to be in a predetermined change control plan in a marketing submi...

FDA Denies Ferring Reconsideration Petition

[ Price : $8.95]

FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restriction...

Test and Report Leachable Nitrosamines: FDA

[ Price : $8.95]

An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosami...

NeuroOnes Trigeminal Nerve Ablation Cleared

[ Price : $8.95]

FDA clears a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to cr...

Multiple Les Encres Violations

[ Price : $8.95]

FDA warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for ad...

Alcohol Use Disorder Drug Gets Fast Track

[ Price : $8.95]

FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.

Cancer Radiopharm. Dosage Guide

[ Price : $8.95]

FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Deve...

Stealth Refiles NDA for Barth Syndrome Drug

[ Price : $8.95]

Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.

Court Orders FDA to Reconsider Vanda sNDA

[ Price : $8.95]

An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep ...