By Jennifer Corbett Dooren WASHINGTON—The Food and Drug Administration has approved 20 new drugs so far this year, just one short of the total for all of 2010, according to a top agency official. The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few […]
CSL influenza vaccine investigation 'inadequate'
By Nick Evans, Perth Now US REGULATORS have hammered Australian vaccine maker CSL over its “inadequate” investigation of manufacturing problems that may have led to severe reactions in children given the flu vaccine last year. In April last year Australian health authorities withdrew CSL’s season flu vaccine from use in children under five after 23 […]
UPDATE 1-FDA accepts Novartis broader Menveo use application
* Menveo protects against a cause of meningitis * Novartis seeking approval in infants and toddlers * Menveo already approved for people 2-55 years ZURICH, June 16 (Reuters) – U.S. authorities have accepted Novartis’s application to broaden use of its meningitis vaccine Menveo, the Swiss drugmaker said on Thursday, giving its Vaccines and Diagnostics unit […]
Cow Fetuses Contaminated Vaccines, FDA Did Nothing
By Jeffry John Aufderheide Media and public relation campaigns literally portray the U.S. FDA as superheroes. For example, the FDA came to the rescue about E. coli tainted spinach, Chinese-made baby formula containing melamine, and even removing salmonella-laced peanut butter from grocery store shelves. Those aforementioned events ought to be the measuring stick for parents […]
Merck Dodges FDA Bullet and Wins Approval for Gardasil Expansion from Health Canada
By Leslie Carol Botha, Vice President Public Relations, SaneVax Inc. PRLog (Press Release) – May 02, 2011 – SANE Vax Inc. is highly disturbed Merck has not taken FDA advice to prove vaccine efficacy in 26 to 45 year old women prior to getting approval from other governments for use in this age group. According […]
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