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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

"This positive opinion underlines two things", explains Dr. Henri Huttunen, Chief Scientific Officer of Herantis. "First, there is a dire need for novel treatments for ALS, which is

The reduction includes approximately 90 positions in the U.S. and Europe. No customer-facing positions within ARIAD’s commercial or medical affairs organizations are included in this action. This reduction

The initial focus of the JV will be immediately advancing ProscaVax, OncBioMune’s novel prostate cancer vaccine combining a tumor-associated antigen with biological adjuvants, into a Phase 2A/2B clinical

The US District Court for Southern Florida ruled that Allergan’s subsidiaries Watson Pharma and Watson Laboratories had infringed on two claims of the Lialda drug patent. Shire senior