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.
The U.S. Food and Drug Administration approved a risk-mitigation plan for a specific class of organ-transplant drugs to warn women about the risk of miscarriages and birth defects. The plan is aimed at drugs containing the active ingredient mycophenolate. The drugs, which include Roche’s CellCept and Novartis’ Myfortic, are used in combination with other medicines to help prevent the body from rejecting a transplanted organ. Fox Business