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Cortex Pharmaceuticals announced it has received notification from the FDA that the clinical hold placed on its Ampakine CX717 in March has been lifted.
Millennium Pharmaceuticals announced that the Journal of Clinical Oncology has published the final results of the PINNACLE trial, one of the largest multicenter studies ever done in the setting of relapsed mantle cell lymphoma (MCL), according to the company.
Pharmaxis announced it has received approval from the UK Medicines Healthcare products Regulatory Agency (MHRA) to begin the UK arm of an international Phase III clinical trial to evaluate Bronchitol in patients suffering from cystic fibrosis.
Berlex, a U.S. affiliate of Schering AG, announced that the FDA has approved Yaz (3 mg drospirenone/20 micrograms ethinyl estradiol) as the first and only oral contraceptive shown clinically effective for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women.
Schering-Plough announced that the European Commission has granted marketing approval to Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the substitution treatment of opioid dependence, within a framework of medical, social and psychological treatment.
3M announced that the FDA has approved its new drug application (NDA) for 3M DuraPrep surgical solution (iodine povacrylex [0.7 percent available iodine] and isopropyl alcohol, 74 percent w/w) patient preoperative skin preparation.
Sirtris Pharmaceuticals that the company's initial clinical candidate, SRT501, was found to be safe and well-tolerated when administered orally in two Phase I clinical studies.