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Discovery Laboratories announced that it received guidance from the FDA at a recent meeting regarding the remaining steps necessary to receive approval for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants.
VioQuest Pharmaceuticals, in partnership with the U.S. Army, has been granted orphan drug designation from the FDA for the active moiety of VQD-001 (sodium stibogluconate) a treatment for the cutaneous form of leishmaniasis.
Chelsea Therapeutics International announced that the FDA has granted orphan drug designation to Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, a group of diseases that includes Parkinson's disease, pure autonomic failure and multiple systems atrophy.
GenVec announced it is collaborating with the Naval Medical Research Center (NMRC) to conduct the first clinical study of an experimental malaria vaccine based on the company's gene-delivery and cell-culture technologies for the production of recombinant adenovirus vaccine vectors.
Penwest Pharmaceuticals has begun a Phase I safety study of a nalbuphine hydrochloride extended-release tablet formulation, Nalbuphine ER, that the company is developing for the treatment of pain.
Computer Sciences Corp. (CSC) announced that its subsidiary DynPort Vaccine, in conjunction with Baxter Healthcare, has initiated a Phase I clinical trial for plasma-derived butyrylcholinesterase, or BioScavenger, which is being developed to prevent and possibly treat effects of exposure to certain chemical nerve agents.
Pharmos announced preliminary results from its Phase IIa study evaluating intravenous cannabinor, a CB2-selective synthetic cannabinoid compound, in a capsaicin-induced pain model.
BioMS Medical has received clearance from the FDA for its investigational new drug application to begin a pivotal Phase III trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive multiple sclerosis (MS).