The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" generics, rejecting Amarin Pharma's infringement claims involving the cardiovascular drug Vascepa
FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease community advocates in an effort to rebuild a fractured relationship.
The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" generics, rejecting Amarin Pharma's infringement claims involving the cardiovascular drug Vascepa
FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease community advocates in an effort to rebuild a fractured relationship.
Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successful.
Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.
