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FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Development.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...
FDA announces a two-day virtual public workshop to address methodological challenges in using patient experience data in drug development and regulato...
FDA grants Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associated steatohepatitis.
