Pfizer's bipolar disorder drug Geodon receives expanded FDA approval Pfizer Inc. said Friday the Food and Drug Administration approved Geodon as a part ...
Covidien says FDA extends review on pain drug Exalgo to Feb. 22 Health care company Covidien PLC said Friday the Food and Drug ...
FDA panel backs stronger benefit claims and safety profile for inhaler drug Spiriva Federal health experts on Thursday brushed off lingering safety questions about a popular inhaler drug and suggested it carry bolder benefit claims. The Food and Drug Administration's panel of ...
BETHESDA, Maryland (Reuters) - More safety data would be needed before a new type of influenza vaccine made in insect cells should get approval, federal advisers said on Thursday. A divided committee advising the U.S. Food and Drug Administration said the new ...
FDA issues warning letters to 22 Web sites, alleges illegal sales of medical products The Food and Drug Administration said Thursday it issued 22 warning letters to Web site operators over alleged illegal sales of unapproved or misbranded drugs. The agency said ...
FDA panel backs stronger benefit claims for inhaler drug Spiriva marketed by Pfizer Federal health experts say an inhaler drug from a German drugmaker works well enough to carry bolder claims about reducing coughing, wheezing and other respiratory problems. The Food and ...
WASHINGTON (Reuters) - Advanced Cell Technology, a small Massachusetts-based biotechnology company, said on Thursday it has asked for approval to test human embryonic stem cells in treating a rare cause of blindness. The company said it filed an IND, an investigational new ...
ZURICH (Reuters) - Actelion Ltd, Europe's largest biotech company, said on Thursday the U.S. Food and Drug Administration (FDA) would review use of its drug Zavesca to treat a rare neurodegenerative disease early next year. The FDA has granted priority review for ...
WASHINGTON (Reuters) - Vaccine makers praised the U.S. response to the swine flu pandemic on Wednesday but said regulatory delays and public suspicion have held up innovative ways to speed and stretch the U.S. influenza vaccine supply. Pharmaceutical executives said their companies ...
FDA panel says next-generation anti-bacterial vaccine from Pfizer works for children Federal health experts said Wednesday an updated version of Pfizer's best-selling anti-infection vaccine is safe and effective for infants and toddlers, despite company studies that failed to meet certain goals. The ...
WASHINGTON (Reuters) - A U.S. Senate committee voted unanimously on Wednesday to increase government oversight of food safety but the first significant overhaul in 50 years may not happen until 2010. Pressure to overhaul the food safety system has grown following several ...
Genentech, Biogen Idec get FDA request on application for Rituxan's use in leukemia Genentech Inc. and partner Biogen Idec Inc. said Wednesday the Food and Drug Administration is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further ...
