FDA doc reveals agency charged Immunomedics with data integrity breach after August plant inspection
Having spent over three decades without an approval, Immunomedics has a troubled past that culminated in a management shakeup at the behest of an activist shareholder campaign that was meant to rejuvenate the company’s fortunes. But that hope was shattered when the FDA rejected the company’s breast cancer drug in January, citing manufacturing issues.
To be sure, the company was not expecting the rejection. It hired a sales force back in November in anticipation of the January approval and told analysts in December that manufacturing issues the US health regulator had flagged in August had since been addressed.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.