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BioSante Pharmaceuticals announced that it received FDA approval for the marketing of Bio-E-Gel. Bio-E-Gel (estradiol gel), which will be marketed under the name Elestrin, is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.
Indevus Pharmaceuticals announced that the FDA has accepted for review its new drug application (NDA) for Sanctura XR (trospium choloride), a once-daily formulation of Sanctura, for the treatment of overactive bladder.
Gilead Sciences has submitted a new drug application to the FDA for ambrisentan (5 mg and 10 mg) for the once-daily treatment of pulmonary arterial hypertension (PAH).
Novartis announced today that the FDA review period has been extended by up to three months for the new drug application (NDA) for Tekturna (aliskiren), which was submitted for approval earlier in 2006 to become the first in a new class of blood pressure medicines for in than a decade.
Perrigo announced that the FDA has issued an approvable letter for Dexcel Pharma Technologies's new drug application (NDA) for 20-mg omeprazole delayed-release tablets.
Wyeth Pharmaceuticals has announced that the FDA has accepted and granted priority review to the company's new drug application (NDA) for Torisel (temsirolimus).
CytRx has announced plans to initiate additional animal stroke-recovery studies with its lead oral drug candidate arimoclomol, currently being evaluated as a therapeutic for amyotrophic lateral sclerosis.
Theratechnologies has announced positive top-line results for its Phase III clinical trial, testing the company's lead compound, TH9507, in patients with HIV-associated lipodystrophy.