FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...
FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.
Federal Register notice: FDA sends to OMB an information collection entitled Pilot Survey to Develop Standardized Reporting Forms for Federally Funded...
FDA proposes to expand options for drug companies seeking to market a nonprescription drug product to allow an additional condition for potential nonp...
Federal Register notice: FDA announces that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemental NDA for Rinvoq (...
FDA places a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors after receiving reports of an eye inflam...
FDAs Vaccines and Related Biological Products Advisory Committee meets to discuss whether and how the SARS-CoV-2 strain composition of Covid-19 vaccin...