FDA launches a new meeting minutes pilot program aimed at reducing delays and confusion that often follow formal meetings between the agency and drug ...
Siemens Healthineers issues an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastro...
Aesculap Implant Systems agrees to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly sold defective knee r...
A business TV station in India says two persons have been arrested for impersonating FDA officials and attempting to extort Hetero Drugs.
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...
