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Unigene Laboratories has received approval from the FDA for Fortical calcitonin-salmon (rDNA origin) nasal spray, its patented nasal calcitonin product for the treatment of postmenopausal osteoporosis.
Merck has announced that U.S. regulators have approved use of its already marketed hepatitis A vaccine for children as young as 12 months old, rather than the previous approved use for patients at least two years of age.
Labopharm has announced that it has secured a U.S. partner to market and distribute its once-daily painkiller Tramadol, which is not yet approved in the U.S. The Laval, Quebec-based drugmaker said it has granted Purdue Pharma, the right to market, sell and distribute the painkiller in the U.S.
Ascentia Biomedical has reached an option agreement with the University of Washington (UW) to develop treatments for a number of diseases using a family of compounds developed by the UW's medical school.
Bayer HealthCare has presented safety and efficacy results from two large randomized Phase II studies for a novel, oral, direct Factor Xa inhibitor (BAY 59-7939) for prevention of venous thromboembolism (VTE).
Predix Pharmaceuticals has announced the initiation of its first Phase III trial of PRX-00023, a 5-HT1A agonist, in patients with generalized anxiety disorder (GAD).
Connetics announced the positive outcome of its Phase III clinical trial evaluating Desilux (desonide) VersaFoam-EF, a low-potency topical steroid formulated in the company's proprietary emollient foam delivery vehicle to treat atopic dermatitis.