The U.S. Food and Drug Administration (FDA) approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease (vWD).
The U.S. Food and Drug Administration approved once-daily Veramyst? (fluticasone furoate) Nasal Spray to treat seasonal and year-round allergy symptoms in adults and children two years of age and older. Veramyst will be available by prescription nationwide by late May 2007.
We at the Blue Buffalo Company have just learned that American Nutrition Inc. (ANI), the manufacturer of all our cans and biscuits, has been adding rice protein concentrate to our can formulas without our knowledge and without our approval.
The Denver office of the FDA informed American Nutrition, Inc. that certain samples of rice protein shipped to its production facility have been contaminated with melamine, an industrial chemical used to make plastics and fertilizers that may be harmful to animals if consumed. The rice protein in question was obtained from San Francisco-based Wilbur-Ellis Company.
Vitamin C is possibly the most important small molecule whose biosynthetic pathway remained a mystery. That is until now. A group of Dartmouth and UCLA researchers, who normally work on genes involved in aging and cancer in animals, discovered the last piece of the puzzle, they report in a study published online April 26 in the Journal of Biological Chemistry.
Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved an update to the ORENCIA? (abatacept) product labeling regarding the progression of structural joint damage — an important measure in the treatment of rheumatoid arthritis (RA).
Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for SINGULAIR? (montelukast sodium) to prevent exercise-induced bronchoconstriction (EIB; also known as exercise-induced asthma) in patients aged 15 years and older.
Solvay announced that its dossier for intravenous tedisamil (intended brand name: PULZIUM? IV), a new chemical entity coming from Solvay Pharmaceuticals R&D laboratories, has been filed for approval by the US Food and Drug Administration (FDA) as well as by the authorities of European U nion countries.
Abbott announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted a positive opinion recommending approval of HUMIRA? (adalimumab) for the treatment of severe Crohn’s disease.
Janssen-Cilag International NV announced that the Committee for Human Medicinal Products (CHMP) in the European U nion, has granted a positive opinion recommending approval of INVEGA? (paliperidone prolonged release tablets). INVEGA? is a new, once-daily, prolonged release oral medication, for the treatment of schizophrenia.