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FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restriction...[ Price : $8.95]
An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosami...[ 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...[ Price : $8.95]
FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Deve...[ Price : $8.95]
Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.[ Price : $8.95]
An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep ...[ Price : $8.95]
A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS se...[ Price : $8.95]
Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related is...