FDA warns North Bergen, NJ-based DermaRite Industries about CGMP, unapproved new drug, and misbranded drug violations in its production of over-the-co...
FDA approves Genmabs Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymph...
FDA warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug Maplifa.
FDA approves an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chyl...
Roche says its investigational selective estrogen receptor degrader giredestrant significantly improved invasive disease-free survival in certain peop...
FDA warns Opa-Locka, FL-based World Perfumes about CGMP violations in its production of finished drugs as a contract manufacturer.
FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Drug User Fee Amendments during a recent meeting at t...
Former CDER chemistry, manufacturing and controls (CMC) reviewer Fabiola Cervantes-Gomez joins Hyman, Phelps & McNamaras as a CMC regulatory expert.
