FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubruti...
FDA warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondicherry, Puducherry, ...
FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could r...
CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draft guidances on aspec...
