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This action has been taken after Novartis notified the FDA about a retrospective analysis of data from more than 18,000 patients in the clinical trial database. The analysis

While the interim analysis of data following the completion of treatment of the first 21 patients demonstrated disease stabilization, the study did not achieve the primary tumor response

The FDA also said that there would have to be a warning section for the company’s older drug for sleepiness Provigil. The draft labeling includes a proposed bolded

The drug helped many patients effectively control their symptoms and maintain their improvements in personal and social functioning. These studies provided longer-term follow-up to the three previously completed

Severe congenital Protein C deficiency results in a hypercoagulable state, meaning there is an abnormal tendency for blood clotting. This can cause severe, often life-threatening blood clots in

<p>Roche will pay $140 million in cash, and up to approximately $14.9 million will be received from the exercise of stock options prior to the acquisition. <br /><br

Oral chemotherapy Xeloda is already replacing standard intravenous therapy 5-fluorouracil (5-FU) in other gastrointestinal cancers. Xeloda on its own is already available in colorectal cancer that has spread

Astellas will pay $20 million upfront and will make up to five additional annual payments of $20 million. Upon commercialization of any antibody products discovered utilizing VelocImmune, Astellas

Vivus is eligible to receive an upfront payment of $10 million upon the closing and an additional $140 million upon the approval of the new drug application for