AstraZeneca withdraws an Imfinzi (durvalumab) indication, treating previously treated adult patients with locally advanced or metastatic bladder cance...
FDA issues a new guidance and revises another to assist vaccine, diagnostic and therapeutic product developers to address the emergence and potential ...
FDA tells BrainStorm Cell Therapeutics that current Phase 3 data will not demonstrate substantial evidence to support a BLA for NurOwn (autologous MSC...
FDA acting commissioner Janet Woodcock announces updated guidance for currently authorized Covid-19 vaccines and diagnostic tests that could be modifi...
FDA clears a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate peripherally insert...
FDA Review posts the Federal Register notices for the week ending 2/19/2021.
Federal Register notice: FDA requests notification from public stakeholders of their intent to participate in periodic consultation meetings on reauth...
Federal Register notice: FDA announces the availability of recent guidance documents related to the Covid19 pandemic.