For Amgen’s Nplate, No News Is Good News
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA tells biotech the agency will miss once-postponed July 23 user fee date.
You may also be interested in...
For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year's final tally may look very similar to last year's record-low approval total
For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year's final tally may look very similar to last year's record-low approval total
FDA’s Cardio-Renal Division Kicks Off August With Three Approvals
The Medicines Co.’s IV therapy Cleviprex plus Novartis’ drug-drug combos, Exforge and Diovan HCT, are approved.