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...
FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the agency says is intende...
FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic cancer.
FDA approves a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.
