Yale University researchers say loopholes in the FDA dermatologic device review process allow potentially dangerous changes without adequate evaluatio...
FDA orders a Boxed Warning on Intercept Pharmaceuticals liver disease drug Ocaliva (obeticholic acid) after determining that it is being incorrectly d...
Federal Register notice: FDA announced a 2/1 public workshop entitled Best Practices in Modeling and Simulation for Oncology Products.
Federal Register notice: FDA determines that for patent extension purposes the regulatory review period for Les Laboratoires Serviers Corlanor (ivabra...
FDA grants Grnenthal an expedited access pathway designation for Vivo, a surgical sealant proposed for being an adjunct to standard closure techniques...
FDA approves B. Braun Medicals 0.9% sodium chloride injection, USP in the Ecoflac Plus 500 mL container.
A federal judge sentences the former head pharmacist at New England Compounding Center to eight years imprisonment and other sanctions for his role in...
The American Heart Association says that more research is needed in the relationship between breast cancer and cardiovascular disease in women.