12 hours ago | News
Astex Pharmaceuticals, Inc. has announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 with one person abstaining that data in their partner Eisai's supplemental new Drug Application (sNDA) for DACOGEN(R) (decitabine) for Injection did not support a favorable benefit-risk profile for the treatment of acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.
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22 hours ago | News
Wholistic Herbs Inc. of Dallas, TX, is recalling all quantities of the following two, 1 fl. oz. spray products distributed from March 2009 through February 2012. Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight...
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Feb 9 | News
ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837 is expanding its recall of sliced herring fillet (forelka) 330 gram and 600 gram in plastic packaging due to Listeria contamination. Listeria monocytogenes is an organism which can cause serious and sometimes...
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Feb 9 | News
The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
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Feb 9 | News
An FDA panel on Wednesday voted 12-1 that the benefits of Amgen’s Xgeva (denosumab) did not outweigh its risks in patients with castrate-resistant prostate cancer (CRPC).
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Feb 9 | News
The FDA warned that proton-pump inhibitors (PPIs) can trigger the development of Clostridium difficile-associated diarrhea (CDAD).
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Feb 9 | Video
CNN’s The Situation Room discusses the current dispute over health care coverage for contraception. Will there be a contraception compromise?
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Feb 8 | News
In order to maintain the highest standards of product quality and safety for Spartan Stores, Michael Foods, Minnetonka, MN., a producer of hard-boiled eggs is initiating a voluntary product withdrawal on one lot code of hard-boiled eggs due to a possible contamination of Listeria monocytogenes.
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Feb 8 | News
CAMBRIDGE, Mass. (AP) — Move over, coffee and Red Bull. A Harvard professor thinks the next big thing will be people inhaling their caffeine from a lipstick-sized tube. Critics say the novel product is not without its risks.
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Feb 8 | News
Amgen will discuss the data from the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases (spread of cancer to the bone) at today's meeting of the U.S. FDA Oncologic Drugs Advisory Committee (ODAC).
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