Orexo AB

The skinny lineup of applications with US FDA user fee goal dates in July is heavy on incremental benefits from formulation technology, the Pink Sheet US FDA Performance Tracker’s User Fee Goal Date

Moderna, Inc. ’s respiratory syncytial virus vaccine will become the next application to miss its Prescription Drug User Fee Act goal date for a US Food and Drug Administration decision, suggesting th

After abuse-deterrent opioid formulations reached a dead-end, the US Food and Drug Administration again is seeing growth in applications for new products that address the opioid crisis. In addition to

After abuse-deterrent opioid formulations reached a dead-end, the US FDA is again seeing growth in applications for new products that address the opioid crisis, led by not one but two applications for