Amgen's Parsabiv's EU Approval Contrasts With US FDA Rejection
Executive Summary
Follow-on hyperparathyroidism product likely needs to resolve safety issues with US agency, analysts say, but extensive data package, including a head-to-head trial, has satisfied European regulators.
You may also be interested in...
Keeping Track: US FDA Approves Emflaza And Parsabiv, Turns Down Opioid/Anti-Emetic Combo CL-108
The latest drug development news and highlights from our FDA Performance Tracker.
Amgen's Parsabiv Approved With Unusual Postmarketing Requirements
US FDA obliges hypothesis-testing observational study to determine whether there is an association with gastrointestinal bleeding and the drug; postmarketing requirements usually seek to determine frequency between a drug and adverse events known to be associated.
Keeping Track: Arymo ER Approved, Parsabiv Returns, Merck Surprises With Keytruda Chemo Combo Submission
The latest drug development news and highlights from our FDA Performance Tracker.