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MGI Pharma and SuperGen announced that they have received an approvable letter from the FDA for Dacogen injection for the treatment of myelodysplastic syndromes (MDS).
Forbes Medi-Tech has submitted an investigational new drug application to the FDA to initiate a Phase II clinical trial for its cholesterol-lowering drug, FM-VP4.
VaxGen has announced that a study published in the September issue of the Journal of Virology provides data showing that a single dose of VaxGen's smallpox vaccine candidate LC16m8 provides mice with 100 percent protection from vaccinia, a relative of the smallpox virus.
Altachem Pharma has received clearance from the Therapeutic Products Directorate of Health Canada to initiate a Phase I clinical trial to investigate the topical application of its lead photodynamic therapy (PDT) compound ACP-SL017 as a treatment for actinic keratosis, a potentially serious precancerous skin condition.
MedImmune has reported that data from a Phase I study demonstrated that Numax appears to have an acceptable safety profile in infants infected with respiratory syncytial virus (RSV).
Allos Therapeutics has announced the publication of results from its Phase II multicenter study of efaproxyn in patients with unresectable non-small cell lung cancer (NSCLC) receiving sequential chemoradiotherapy (S-CRT).
Cognetix announced that the FDA has granted an orphan-drug designation to its
lead compound, CGX-1160, for the intrathecal treatment of neuropathic pain associated
with spinal cord injury.
ImClone Systems has submitted an application to U.S. regulators to expand the
approval of its Erbitux cancer treatment to include head and neck cancer, meeting
a revised filing schedule.