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As agreed with FDA, ceftazidime-avibactam was submitted as a 505(b)(2) NDA for the treatment of patients with cIAI and cUTI based on the efficacy and safety of ceftazidime,

The addition of BONINE provides significant scale to its U.S.OTC nausea franchise. Its EMETROL brand is the #1 pharmacist recommended nausea remedy, and has provided consumers with relief

These two are life-threatening fungal infections predominantly occurring in immunocompromised patients. The FDA has designated the date of 8 March 2015 for the completion of the review, in

Discovered and developed by Takeda, Leuplin is an LH-RH agonist that stimulates the pituitary gland, resulting in suppressed production of male/female hormone. The NDA is based on the

The new grant will support the completion of a Phase IIa trial of MN-166 in opioid dependence, for which the company had recently released positive interim results. The

The approval was based on data from a Phase III registration program, which showed that ferric citrate reduced serum phosphorus levels to well within the KDOQI guidelines range

The indication of Keytruda 2mg/kg every three weeks is approved under accelerated approval based on tumor response rate and durability of response. Keytruda, the first anti-programmed death receptor-1

As part of the deal, Navidea will earn royalties on units sales, an upfront payment of $300,000, up to $700,000 in development milestone payments and up to $1.5m

The Public Health Agency of Canada (PHAC) has initially developed the vaccine, which is under an exclusive licensing arrangement with BioProtection Systems, a subsidiary of NewLink Genetics. The