The US FDA has rejected Astellas Pharma’s application for the first drug approval for gastrointestinal cancer treatment, zolbetuximab, due to “unresolved deficiencies” in its manufacturing process. Despite the setback, Astellas confirmed that there had been no concerns raised over the safety or efficacy of the drug. Zolbetuximab is aimed at patients with HER2-negative, locally advanced or metastatic gastrointestinal adenocarcinoma, which currently lacks sufficient treatment options. Astellas acquired the drug as part of its 2016 purchase of Ganymede Pharmaceuticals.
Trump turns over new leaf in GOP drug policy with marijuana, psychedelics orders
The Trump administration’s moves on marijuana and psychedelics signal the start of a new era in Republican drug policy. The orders to fast-track reviews of
