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Ohm Laboratories, a wholly owned subsidiary of Ranbaxy Laboratories, announced it has received FDA approval to manufacture and commercialize its generic loratadine orally disintegrating tablets, 10 mg.
GlaxoSmithKline (GSK) announced that the FDA has approved its antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection.
The FDA's Arthritis Advisory Committee voted 20-1 against recommending approval of Merck's Arcoxia, a potential successor to Vioxx as a treatment for arthritis pain.
Roche presented data analyses from a large registration trial program to provide efficacy and safety information on Mircera for the treatment of renal anemia associated with chronic kidney disease (CKD) at the National Kidney Foundation Spring Clinical Meeting.
Idenix Pharmaceuticals has announced results from two Phase IIb studies of the novel combination of valopicitabine and Pegasys in both treatment-naive and treatment-experienced patients infected with the genotype-1 strain of the hepatitis C virus (HCV).
Pharmaxis has announced the launch of a Phase III trial of Bronchitol that is being conducted initially in 40 hospitals across Australia, the UK and Ireland.
Dyax has announced positive topline results from its Phase III, placebo-controlled trial, EDEMA3, for its lead product candidate DX-88, for hereditary angioedema (HAE).
Advanced Magnetics announced positive results from two additional Phase III clinical trials of ferumoxytol as an intravenous (IV) iron replacement therapeutic.