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The TGA Transparency Review Report comprises recommendations relating to the labelling of medicines. The TGA will be considering the submissions to the review and the relevant sections of

In its CRL, the FDA has rejected to approve the drug in its present form and has requested information related to the product quality or CMC matters. Additionally,

As per the terms of the CRADA, Division of Cancer Treatment and Diagnosis (DCTD) of NCI intends to sponsor PCI-32765 Phase 1 and Phase 2 trials in certain

The company expects to start operations in the new formulation plant in the second half of 2012. Lonza Nutrition business unit head Roman Quinter said by developing ready-made

Arena’s net loss was $22.91m, or $0.16 loss per diluted share, compared to net loss of $28.76m, or $0.28 loss per diluted share, for the same period in

The study aims to investigate the efficacy and safety of AX200 as a treatment for acute ischemic stroke. The company anticipates to release initial findings of the AXIS

The submission of the NDA is based on the safety and efficacy data from a Phase 3 program consisting four double-blind placebo-controlled trials and two open-label long term

Medigent DIS of DeltaWare Systems, the Canadian business unit of Maximus, offers up-to-date profiles and information for improved health planning, evaluation and research. The Medigent DIS will be

Horizant is XenoPort’s first approved product. Horizant extended-release tablets are indicated for the management of postherpetic neuralgia (PHN) in adults patients. GSK holds commercialization rights and certain development