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...
A new CDER Office of New Drugs annual report highlights some of its work with sponsors to advance innovative clinical trial designs.
FDA issues a clinical hold on Astellas Pharmas FORTIS Phase 1/2 gene therapy trial following a report of peripheral sensory neuropathy in one of the t...