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ChemGenex Pharmaceuticals announced that its investigational drug Ceflatonin (homoharringtonine, HHT) has been awarded fast-track status by the FDA for the treatment of patients with chronic, accelerated and blast-phase chronic myeloid leukemia (CML) who have failed on Gleevec and have the T315I bcr-abl point mutation.
Synta Pharmaceuticals announced that its lead oncology drug candidate, STA-4783, has been granted fast-track designation by the FDA for the treatment of metastatic melanoma.
Favrille announced that a data monitoring committee (DMC) completed its prospectively planned interim analysis of a secondary endpoint in the first 233 patients enrolled in the company's ongoing randomized, double-blind, placebo-controlled, Phase III clinical trial of FavId following Rituxan induction therapy in patients with follicular B-cell non-Hodgkin's lymphoma (NHL).
Immunomedics announced that its partner, UCB, has received notification from FDA that the clinical hold on Phase III trials with epratuzumab in patients with lupus has been lifted.
Vanda Pharmaceuticals has announced positive top-line results from the company's Phase III clinical trial evaluating VEC-162, a balanced melatonin receptor agonist, in transient insomnia.
Abbott has announced that the FDA approved an expanded indication for Humira (adalimumab) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis.
Alexion Pharmaceuticals announced that the FDA has accepted the company's biologics license application (BLA) for Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Cangene announced that its Varicella zoster immune globulin, VariZIG, has received orphan drug designation from the FDA for passive immunization of exposed, susceptible individuals who are at risk of complications from varicella.