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Avanir Pharmaceuticals has received an approvable letter from the FDA for a new formulation of its currently marketed antipsychotic drug FazaClo (clozapine).
DOR BioPharma has received notification from the FDA that the Oncology Drug Advisory Committee (ODAC) will review the company's new drug application (NDA) for orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-versus-host disease (GI GVHD) May 9.
Lexicon Genetics has begun a Phase Ib clinical trial of LX6171, its oral drug candidate for the treatment of cognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia and vascular dementia.
Gloucester Pharmaceuticals has reached an agreement with the FDA under the special protocol assessment (SPA) process for the design of its planned Phase II pivotal trial of romidepsin in patients with peripheral T-cell lymphoma (PTCL).
Threshold Pharmaceuticals has initiated patient enrollment in a Phase II clinical trial evaluating the dosing, safety and activity of glufosfamide in patients with platinum-resistant ovarian cancer.
YM BioSciences announced that the independent data safety monitoring board (DSMB) for the pivotal Phase III trial of tesmilifene in patients with metastatic or recurrent breast cancer has completed its third planned safety and efficacy analysis.
Polydex Pharmaceuticals has reported that that Conrad, a reproductive health research organization, has halted a Phase III clinical trial of Ushercell -- a cellulose sulfate topical microbicide gel being tested for HIV prevention in women -- because preliminary results at some trial sites indicated that cellulose sulfate could lead to potential increased risk of HIV infection in women who use the compound.
Pharmion has received approval from the FDA for its new drug application supplement to add intravenous (IV) use as a new route of administration to the approved prescribing information for its DNA demethylating agent Vidaza (azacitidine for injection).