FDA calls NovaDel’s NitroMist submission complete
The FDA requested on June 1, 2005 that NovaDel provide certain additional manufacturing process validation data which the company submitted on May 3, 2006. After confirming that the
The US Food and Drug Administration (FDA) has approved two Jazz Pharmaceuticals regimens containing Ziihera (zanidatamab-hrii) for the first-line treatment of adults with unresectable, locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastroesophageal adenocarcinoma (GEA).