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Novo Nordisk announced that the FDA has approved NovoLog (insulin aspart [rDNA origin] injection) for pregnancy Category B rating, further validating NovoLog as a safe and effective treatment for pregnant women with Type 1 diabetes.
Par Pharmaceutical announced it has received final approval from the FDA for its abbreviated new drug application for generic propranolol hydrochloride extended-release (ER) in 60-, 80-, 120- and 160-mg capsules.
Teva Pharmaceutical Industries announced that the FDA has granted final approval for the company's abbreviated new drug application (ANDA) to market its generic version of Novartis' Focalin (dexmethylphenidate hydrochloride), 2.5-, 5- and 10-mg tablets.
Alfacell announced that the FDA has granted orphan drug designation to the company's lead drug candidate, Onconase (ranpirnase), for treatment of malignant mesothelioma.
Nutra Pharma announced that its subsidiary ReceptoPharm had commenced its Phase IIb clinical trial of subjects with adrenomyeloneuropathy, a genetic disorder that affects the nervous system.
Sunesis Pharmaceuticals has reported initial results from the first stage of two Phase II clinical trials of SNS-595, a novel cell-cycle inhibitor, in first-line relapsed/refractory small-cell and non-small-cell lung cancer.
Cytos Biotechnology has announced positive results from a Phase IIa study of CYT006-AngQb, a therapeutic vaccine candidate for the treatment of hypertension.
OSI Pharmaceuticals and Roche, its international partner for Tarceva (erlotinib), announced that the European Commission has granted marketing authorization for Tarceva in combination with Gemzar (gemcitabine) as first-line therapy for metastatic pancreatic cancer.