We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Biopure has announced that the independent data and safety monitoring board (DSMB) for the company's Phase II clinical trial of Hemopure (hemoglobin glutamer [bovine]) in trauma patients has completed its first scheduled interim analysis of blinded study data and recommended that the trial continue without modification.
CombinatoRx has announced positive preliminary results from its randomized, blinded, placebo-controlled Phase II clinical trial of CRx-102 in rheumatoid arthritis (RA).
Accentia Biopharmaceuticals will begin enrolling patients in its Phase III study of SinuNase, including patients with severe chronic sinusitis refractory to sinus surgery.
Novelos Therapeutics announced that the first patient has been enrolled in the pivotal Phase III trial in advanced non-small-cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy.
MedImmune has announced preliminary results from a Phase III pivotal study showing that Numax met its primary endpoint of noninferiority by reducing the incidence of hospitalizations caused by respiratory syncytial virus (RSV) in infants at high risk for serious RSV disease by 26 percent when compared with Synagis (palivizumab).
Impax Laboratories announced that the FDA has granted approval of the company's abbreviated new drug applications (ANDA) for generic versions of Urecholine Tablets (bethanechol chloride tablets) 5, 10, 25 and 50 mg.
Adolor and GlaxoSmithKline (GSK) announced that the FDA has issued a letter stating that the new drug application (NDA) for Entereg (alvimopan) 12 mg for the management of postoperative ileus is approvable.
Encysive Pharmaceuticals announced that, following discussions with the FDA, the company has submitted a complete response to the approvable letter issued by the FDA in July regarding the company's new drug application for Thelin (sitaxsentan sodium) 100-mg tablets.