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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...

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FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Deve...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

Advisory Panel Conflicts of Interest Low: Study

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A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS se...

Tandem Recalls Insulin Pumps Due to Alarm Error

[ Price : $8.95]

Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related is...