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Elan and Biogen Idec have announced the submission of a supplemental biologics license application (sBLA) to the FDA seeking approval to market Tysabri (natalizumab) as a treatment for patients with moderately to severely active Crohn's disease.
Advancis Pharmaceutical has filed a new drug application (NDA) with the FDA for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with pharyngitis/tonsillitis via the 505(b)(2) regulatory pathway.
Johnson & Johnson (J&J) Pharmaceutical R&D has submitted a new drug application to the FDA for doripenem, an investigational carbapenem antibiotic, for the treatment of complicated intra-abdominal and complicated urinary tract infections.
GlaxoSmithKline (GSK) has confirmed that, due to insurmountable issues regarding formulation, development of brecanavir, an investigational protease inhibitor for the treatment of HIV, has been discontinued.
VaxGen announced that the FDA's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine, rPA102.
Critical Therapeutics has announced that the NIH will sponsor and fund a clinical trial to evaluate whether using Zyflo (zileuton tablets) to treat patients admitted to the hospital with acute exacerbations of chronic obstructive pulmonary disease (COPD) will shorten their hospital stay.