A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
Johnson & Johnson settled a lawsuit on the first day of a trial over claims its antipsychotic drug Risperdal (risperidone) caused a male plaintiff to grow breast tissue, one of his lawyers told a state judge in Philadelphia. Bloomberg