Pursuant to the agreement, the company may from time to time sell up to a maximum of $20 million of the company's American Depositary Shares (ADSs

The drug's PDUFA date is Aug. 26

Earlier this month, Alimera resubmitted the new drug application for Iluvien, which has a PDUFA date of Oct. 17

QRxPharma Ltd., of Sydney, Australia, said the FDA set a PDUFA date of Aug. 26 for the resubmitted new drug application seeking approval of Moxduo, an immediate-release dual opioid pain therapy that combines morphine and oxycodone

QRxPharma Ltd., of Sydney, Australia, said the FDA set a PDUFA date of Aug. 26 for the resubmitted new drug application seeking approval of Moxduo, an immediate-release dual opioid pain therapy that combines morphine and oxycodone

The PDUFA date for the sNDA is Oct. 21

The PDUFA date for tivozanib, a once-daily, VEGF receptor tyrosine kinase inhibitor, is July 28. (See BioWorld Today, Jan. 4, 2012, and Aug. 6, 2012...Titan submitted the application in October under the 505(b)(2) pathway, and the NDA was granted priority review, with a PDUFA date of April 30

The FDA classified the resubmission as a complete, Class 1 response to its October 2012 complete response letter and set a PDUFA date of March 31

The PDUFA date is April 29

The PDUFA date will be in the third quarter of this year...QRxPharma Ltd., of Sydney, Australia, said it clarified the steps necessary with the FDA for approval of pain candidate MoxDuo, with a new drug application resubmission expected this quarter and a new PDUFA date set for the third quarter

Hyperion Therapeutics Inc., of South San Francisco, said the FDA advised the company not to expect a final action on its new drug application (NDA) for Ravicti (glycerol phenylbutyrate) by the PDUFA date of Jan. 23...In September, the FDA extended the PDUFA date for its review of Ravicti by three months, citing the need to provide time for a full review of the submission

The PDUFA date for canagliflozin is May 31

The PDUFA date will be in the third quarter of this year

The PDUFA date for canagliflozin is May 31

The drug gained the FDA's blessing late last month, a few days ahead of its PDUFA date, as a long-term treatment for short bowel syndrome (SBS), an ultra-orphan indication

The PDUFA date is April 30

Its PDUFA date is March 17, 2013

Although committee votes are nonbinding, CDER will consider them in making a final determination on the synthetic, double-stranded RNA compound, which has a PDUFA date of Feb. 2, 2013

The PDUFA date is Oct. 3, 2013