An FDA approval document shows that the accelerated approval of Replimune’s Tudriqev came despite significant concerns about the reliability of efficacy results from the company’s Phase 1/2 IGNYTE trial.
FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma.
An FDA approval document shows that the accelerated approval of Replimune’s Tudriqev came despite significant concerns about the reliability of efficacy results from the company’s Phase 1/2 IGNYTE trial.
FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma.
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary Eugia Pharma Specialities, following a February inspection (see earlier story) that identified deficiencies involving aseptic manufacturing, process validation, visual inspection and investigations of complaints involving glass particles. The agency subsequently classified the facility as Official Action Indicated
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set during pressure infusion or flushing, potentially exposing patients to serious injury or death. The issue involves the potential formation of air bubbles in the drip chamber and tubing when a pressure cuff is being used or when the tubing is flushed with the line in the fully open position, according
