Avandia’s future murky after FDA panel vote
The type 2 diabetes drug, already under a black-box warning, is examined again as more questions about its safety are raised.
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FDA can promote personalized medicine: ACLA
The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced way according to the American Clinical Laboratory Association (ACLA). ACLA, which represents the nation’s leading clinical laboratories, says that the factors supporting this approach include the growing role …
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US senator urges release of sunscreen chemical data
A U.S. senator Sunday called on the FDA to reveal findings on a possible link between a chemical found in most sunscreens and skin cancer.
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BioSante’s GVAX CML Vaccine granted FDA Orphan Drug designation
BioSante Pharmaceuticals, Inc. today announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease or condition that affects fewer than 200,000 people in the U.S. Orphan drug …
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FDA clears Amgen’s bone-strengthening drug Prolia
The Food and Drug Administration on Tuesday approved Amgen’s bone strengthening drug, Prolia, for postmenopausal women at risk for fractures, a potential blockbuster market.
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FDA Issues Warning About Proton Pump Inhibitors
The FDA is warning physicians and consumers about a possible increased risk of fractures for the hip, wrist and spine with high doses or long-term use of proton pump inhibitors, or PPIs. The labeling on these products will be changed to describe these risks for both the prescription and OTC product versions, the agency said.
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FDA vs. Jason – and vitamin B17 Janson Vale został skazany za informowanie ludzi o tym, że witamina B17 leczy nowotwory. Fragment ten wychwyciłem przypadkowo oglądając produkcję przytłoczeni spamem, niestety film także pojechał po najniższej linii oporu czyli ignorancji. Janson Vale został skazany przez FDA nie za sapm, a za infromowanie ludzi o B17. W Filmie mamy tylko jedno zdanie o tym, a cała koncepcja próbuje nam wmówić, ze Janson został skazany za spam. Tak działa ta propaganda, i tak aferę z B17 ukrywa się w spamie. Dlaczego FDA tak bardzo boi się witaminy B17 i pestek moreli, zapraszam do artykułu: wolne-media.h2.pl
(AFX UK Focus) 2010-04-20 22:42 UPDATE 3-U.S. FDA staff questions King, Acura pain drug
By Lisa Richwine
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FDA cracking down on fat-melting injections
(AP) — The Food and Drug Administration is cracking down on fat-melting injections used in spas across the U.S., saying the drugs have not been proven safe or effective.
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FDA approves CSL Behring’s Hizentra for PI
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for HizentraTM, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of …
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