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Teva Pharmaceutical Industries announced that the FDA has granted approval to its abbreviated new drug application for generic cabergoline tablets, 0.5 mg.
Encysive Pharmaceuticals announced that the Australian Therapeutic Goods Administration (TGA) has approved its Thelin 100-mg tablets as a once-daily treatment for pulmonary arterial hypertension.
Omrix Biopharmaceuticals announced it has submitted a supplemental biologics license application (sBLA) to the FDA for approval to market Evicel, the company's second-generation liquid fibrin sealant, with an expanded indication of general hemostasis in surgery.
Nuvo Research announced that, based on discussions with the FDA regarding matters raised in its December 2006 approvable letter for Pennsaid, the company plans to begin new studies to support a response to the FDA in the fourth quarter of 2007.
Animal study data stemming from a collaborative project between the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and Eli Lilly shows that a newly discovered compound effectively stops excessive drinking and prevents relapse.
AOP Orphan Pharmaceuticals and Lantibio have announced positive final results from their placebo-controlled, double-blind, Phase II clinical study of Moli1901, an experimental compound to treat cystic fibrosis.
ZymoGenetics announced that the FDA has said it will not be required to conduct an additional Phase III clinical trial of its recombinant human Thrombin (rhThrombin), which aids in controlling bleeding during surgery.
Wyeth Pharmaceuticals and Progenics Pharmaceuticals announced that Wyeth is beginning Phase III clinical testing of a new formulation of oral methylnaltrexone for the treatment of opioid-induced constipation.