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DOR BioPharma has submitted a new drug application (NDA) to the FDA to market orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-versus-host disease (GI GVHD), the most common life-threatening complication of allogeneic, hematopoetic stem cell transplantation.
Alexion Pharmaceuticals announced it has submitted a biologics license application (BLA) to the FDA for Soliris (eculizumab), a treatment for patients diagnosed with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.
Caprion Pharmaceuticals has announced the completion of Phase I studies of Shigamabs, the company's therapeutic product for the treatment of Shiga toxin-producing E. coli infections.
Topigen Pharmaceuticals has announced preliminary data from its first Phase II trial of inhaled TPI-ASM8 as a single agent in patients with allergic asthma.
Progenics Pharmaceuticals and Wyeth Pharmaceuticals have announced the initiation of the first of two global Phase III trials to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of postoperative ileus, a debilitating impairment of the gastrointestinal tract that occurs after surgery.
Alcon announced that the FDA has approved Travatan Z (travoprost ophthalmic solution) 0.004 percent for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to other intraocular pressure-lowering medications.
Vernalis announced that the FDA has accepted the company's supplemental new drug application (sNDA) for Frova (frovatriptan succinate) 2.5 mg tablets for the short-term (six days per month) prevention of menstrual migraine.
Oscient Pharmaceuticals has received an approvable letter from the FDA for the supplemental new drug application (sNDA) seeking approval for the five-day treatment of community-acquired pneumonia (CAP) of mild to moderate severity with Factive (gemifloxacin mesylate) tablets.