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Perrigo announced that its partner, InvaGen Pharmaceuticals, has received tentative approval from the FDA for its generic terbinafine hydrochloride tablets, 250 mg.
Novelos Therapeutics announced that the FDA has granted fast-track designation to NOV-002 for use in combination with first-line chemotherapy for the treatment of advanced non-small-cell lung cancer.
MacuSight announced that the FDA has accepted the company's investigational new drug application for its proprietary formulation of sirolimus (rapamycin).
Novogen's investigational anti-inflammatory compound, NV-52, is entering its second human clinical study following the successful completion of toxicology testing.
Predix Pharmaceuticals has initiated a Phase II trial to evaluate the short-term efficacy and safety of PRX-08066, a serotonin 5-HT2B antagonist, in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
Inspire Pharmaceuticals has terminated its Phase II trial of INS50589 anti-platelet based on the unanimous recommendation of its independent data monitoring committee (DMC), following a planned interim safety analysis.
Corcept Therapeutics announced that an article describing the results of its Phase II clinical trial is available to the public in the Journal of Biological Psychiatry.
Cell Therapeutics has announced that, based on preliminary confirmed and unconfirmed complete response rates observed among the first 40 patients with aggressive non-Hodgkin's lymphoma (NHL) treated in its randomized Phase III trial of pixantrone, the company's data monitoring committee recommended that the study continue.