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The company said its decision was not based on any emerging safety concerns from the phase 3 clinical trials with fulranumab. Janssen Pharmaceuticals is terminating its licensing deal

"FDA’s approval of Defitelio underscores the importance of Defitelio to children and adults as the first and only proven treatment for this rare and often deadly complication of

The new pre-clinical studies demonstrated both a statistically significant reduction of inflammation (65% decrease in F4/80, and 80% decrease in CD64), as well as a statically significant effect

The local ethics committee, responsible for oversight and allowance of the trial, granted this approval, so the trial can now move forward. Cellceutix is now awaiting the country’s

The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date. "This filing is another important step toward our goal of bringing

The deal expands the ongoing life sciences software and cloud-hosting services CSC is delivering to Tokyo-based Eisai’s US pharmaceutical subsidiary until December 2019. CSC has been providing regulatory

Opdivo is currently approved to treat various types of melanoma, lung cancer and kidney cancer. The data supporting the type II variation application was generated in the phase

The companies said the request was expected as part of the regulatory process and they will continue to work with the FTC in connection with the review. Pfizer

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "We continue to move at an unprecedented pace with osimertinib, with the full