Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal wome… Read More »
The FDA has approved Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA… Read More »
Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiat… Read More »
Pharsight Corp., a provider of software and services for clinical drug development, has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER).
Under the terms of the CRA… Read More »