The FDA assigned a PDUFA date of March 27, 2013

The NDA has a PDUFA date of July 28, 2013, and its acceptance triggered a $15 million milestone payment to AVEO

The agency classified the resubmission as a complete, Class 2 response to its March 26, action letter and set a PDUFA date of April 15, 2013

In other news, Orexo said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013

Orexo AB, of Uppsala, Sweden, said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013

10 action letter and has set a PDUFA date of April 30, 2013

Heplisav has a PDUFA date of Feb. 24, 2013

The PDUFA date is Feb. 26, 2013

The PDUFA date for raxibacumab is Dec. 15

Ventrus has started to enroll in its second Phase III pivotal trial, with results expected early fourth quarter 2013, and assuming a successful outcome, expects to file an NDA late in the fourth quarter of 2013 with an anticipated PDUFA date at the end of 2014

The PDUFA date for raxibacumab is Dec. 15

The FDA also granted Ariad's request for priority, accelerated review, and set a PDUFA date of March 27, 2013

The compound is an RNA nucleic acid, and bears a PDUFA date of Feb. 2, 2013

Biogen Idec Inc., of Weston, Mass., said the FDA extended the initial PDUFA date for its review of the new drug application for BG-12 (dimethyl fumarate), the company's oral therapeutic candidate for the treatment of multiple sclerosis, by three months

The PDUFA date is Feb. 5, 2013

A PDUFA date has been set for March 27, 2013

The NDA will be subject to a standard review and will have a PDUFA date of May 31, 2013

The agency told the company the review of the new drug application for pomalidomide is continuing, with the previously disclosed PDUFA date of Feb. 10, 2013

The new PDUFA date is March 17, 2013