FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma.
Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers.
FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma.
Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers.
FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.
FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by Orchid Pharma Limited in India, following an inspection last year.
