Gamida Cell completes a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant.
FDA says a cybersecurity vulnerability in some Illumina next-generation sequencing instruments could affect patient results.
FDA sends Aeglea BioTherapeutics a refusal-to-file letter for its BLA for pegzilarginase, indicated for treating arginase 1 deficiency (ARG1-D), reque...
FDA sets 1/29/23 as the PDUFA action date for a Pfizer/Myovant sNDA to update the labeling of Myfembree.
Atrium Medical recalls its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter hub separating from ...
Three doctors sue FDA over the agencys efforts to prevent the use of ivermectin to treat Covid-19.
FDA says it has pulled its approval of TG Therapeutics Ukoniq for two lymphoma indications due to safety concerns.
FDA launches a Web page, required by the 21st Century Cures Act, on antibacterial and antifungal susceptibility test interpretive criteria.