FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restrictions on ANDAs citing Fi...
An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosamine impurities that c...
FDA clears a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency ...
FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Development.
Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.
An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep drug Hetlioz (tasime...
A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS secretary Robert F. Ke...
Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger...
