Top Republicans on the House Energy and Commerce Committee ask FDA for all documents relating to two closed OCI investigations of the 2008-2009 contam...
Amgen tells the Supreme Court that Sandoz position on biosimilar patent dances and marketing notification would lead to chaos in the Biologics Price ...
FDA clears a Millar, Inc. 510(k) for its Mikro-Cath Pressure Catheter for use in monitoring intracompartmental and airway pressures.
FDA approves Mercks Keytruda (pembrolizumab) for treating adult and pediatric patients with refractory classical Hodgkin lymphoma.
An FDA drug safety alert warns that Allergans Viberzi (eluxadoline), a therapy used to treat irritable bowel syndrome with diarrhea, should not be use...
The House Energy and Commerce Committees health subcommittee schedules a hearing on PDUFA.
Federal Register notice: FDA announces a 3/29 Oncologic Drugs Advisory Committee meeting that will review a Genentech BLA for rituximab/hyaluronidase ...
Federal Register notice: FDA announces a 4/5 public workshop on Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives.