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 warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for adulterated and misbra...
FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.
FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Development.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...
