The treatment is for patients with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or after platinum-based chemotherapy in the metastatic setting, or whose
Aeglea plans to start a phase 1 dose escalation study in the first half of this year in patients with relapsed and refractory acute myeloid leukemia (AML) and
In the phase 3 study of 309 patients with secondary, or high risk, acute myeloid leukemia, those who received Vyxeos on average lived for 9.56 months after the
The 120-patient trial demonstrated that patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39%, compared with a 13% reduction for those on a placebo,
Sarilumab is being developed by Sanofi and Regeneron Pharmaceuticals, while adalimumab is marketed by AbbVie as Humira. Sarilumab is a human monoclonal antibody directed against the interleukin-6 (IL-6)
The agency’s Center for Veterinary Medicine (FDA-CVM) released in the Federal Register a preliminary finding of no significant impact (FONSI) on OX513A for an investigational trial in the
The drug’s use has been expanded to treat patients with advanced, or metastatic, NSCLC whose tumors have an ROS-1 gene alteration, which is believed to lead to abnormal
The drug was studied in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM), a condition in which the heart becomes enlarged and cannot pump blood
The sBLA is based on results from a phase 3 one-year study and its five-year open-label extension trial to assess the safety and efficacy of Enbrel in pediatric
The commission had concerns that the merged entity would have faced insufficient competition from the other rivals for several generic drugs, particularly in the UK Ireland and Iceland.
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