Urinary tract infection agent yields positive phase III study results
Ceftolozane/tazobactam, an investigational antibiotic, showed positive top-line results in a pivotal phase III clinical trial of the drug’s use in complicated urinary tract infections (cUTI), Cubist...
View ArticleJune 2014 Urology Product Preview
FDA accepts pre-chemo application for PCa agent, grants priority review The FDA has accepted for filing the supplemental new drug application to extend the indication for enzalutamide (XTANDI)...
View ArticleSivextro approved to treat skin infections
FDA has approved the new antibacterial drug tedizolid phosphate (Sivextro, Cubist Pharmaceuticals) to treat adults with skin infections. Sivextro can be administered intravenously or orally, and is...
View ArticleFDA approves a new antibiotic to treat MRSA
FDA has approved antibacterial drug tedizolid phosphate (Sivextro, Cubist Pharmaceuticals) to treat adults with skin infections. Sivextro is approved to treat patients with acute bacterial skin and...
View ArticleFDA drug approvals-July 2014
Actions in brief Tavaborole (Kerydin, Anacor Pharmaceuticals) topical solution, 5% was approved, which is the first oxaborole antifungal approved for the topical treatment of onychomycosis of the...
View ArticleFDA approves oritavancin for skin infections
FDA has approved oritavancin (Orbactiv, The Medicines Company) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible...
View ArticleUrology Product Preview: Testosterone agent meets efficacy endpoint in phase...
Testosterone agent meets efficacy endpoint in phase III studiesClarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral...
View ArticleNovel new drugs approved in 2014
FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug...
View ArticleFDA green lights combination antibiotic
FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections...
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