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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 FDA requested additional CMC information for the Multi-Dose Preservative-Free (MDPF) bottle, a first of its kind container with patented uni-directional valve and air filter technology. Allergan is

The shared goal is the identification and validation of novel druggable sites in disease pathways, and the development of a pipeline of novel therapeutic targets in the oncology

The Series B financing was provided by Hiroshi Mikitani through his personal investment companies. Hiroshi Mikitani is the CEO of Rakuten, Inc., one of the world’s leading internet

The Phase 1b portion of the study utilizes a basket design focusing on patients with solid tumors that contain molecular alterations of RET or BRAF. "We are excited

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.