FDA approves an Anixa Biosciences IND for its CAR-T (Chimeric Antigen Receptor-T cell) therapy and its use in treating ovarian cancer.
FDA revises its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency.
FDA grants a de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart knee for total knee ...
FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating glioblastoma multiforme and other malignant gliomas.
Federal Register notice: FDA announces that it has revoked the Emergency Use Authorization issued to Curative Inc. for its Curative SARS-Cov-2 Assay b...
Federal Register notice: FDA makes available two draft device-specific guidance documents for the Safety and Performance Based Pathway one on denture...
FDA Review posts the Federal Register notices for the week ending 8/27/2021.