The US FDA has commenced an inspection of Xspray Pharma’s contract manufacturer NerPharMa, marking a step towards resolving manufacturing compliance issues that have delayed approval of its two cancer treatments, Dasynoc and Nilopki. These deficiencies contributed to the FDA’s previous rejection of Dasynoc in August and Nilopki in June. The inspection’s duration and outcome remain unknown, with satisfactory manufacturing compliance still essential before either treatment can receive US approval.
