Centessa Pharmaceuticals discontinues its development of lixivaptan for autosomal dominant polycystic kidney disease after due to a questionable safet...
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.
Sens. Hassan and Paul introduce a bill to require FDA to more clearly identify differences between a generic and its reference-listed drug.
FDA grants Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory follicular lymphoma af...