GE Healthcares Application For Adreview (Lobenguane I 123 Injection) Accepted By The FDA For Priority Review (Medical News Today)
GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has designated for priority review the New Drug Application (NDA) for AdreView. AdreView is a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients. The FDA also encouraged GE to establish an expanded access program for the agent.

NPS Pharmaceuticals Notified of ANDA Filings for Cinacalcet HCl (Finanzen.net)
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today reported the receipt of Paragraph IV Certification Notice Letters related to certain drug manufacturers Abbreviated New Drug Applications (ANDA) submitted to the U.S. Food and Drug Administration ...

FDA, European Medicines Agency To Consider Additional Test Results That Evaluate Kidney Damage When Assessing New Drug ... (Medical News Today)
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs.