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Consumer groups want tougher probe of engineered salmon
WASHINGTON (Reuters) - Three U.S. consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat. The fish at issue, AquaBounty Technologies' AquAdvantage salmon, is currently classified as a new animal drug for the purposes of FDA review ...
FDA will speed up review of Roche cancer drug
Swiss drugmaker Roche said Tuesday that the Food and Drug Administration will make a decision on its experimental breast cancer drug pertuzumab by June.
FDA questions Amgen drug for prostate cancer
Scientists for the Food and Drug Administration say that an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects.
Prostate cancer drug has side effects
Scientists for the Food and Drug Administration say that an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects. The Food and Drug Administration will ask a panel of outside experts on Wednesday whether the benefits of Amgen’s Xgeva outweigh its risks, which included bone disease in ...
Tech Ticker: FDA questions Amgen drug, Oracle seeks new SAP trial
The Food and Drug Administration will ask a panel of outside experts Wednesday whether the benefits of Amgen's Xgeva outweigh its risks.
US consumer groups want tougher probe of engineered salmon
* Strict FDA review needed for public health-consumer groups * Would be first gene-altered animal for U.S. consumption * No timeline for Food and Drug Administration decision WASHINGTON, Feb 7 (Reuters) ...
FDA question's Amgen drug for prostate cancer
Scientists for the Food and Drug Administration say an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug failed to extend life and carried significant side effects.
FDA questions new use for Amgen drug
Amgen has asked the FDA to approve the injectable drug Xgeva as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. Scientists for the Food and Drug Administration say that an Amgen Inc. drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side ...
Roche breast cancer drug gets FDA priority review
(Reuters) - Health regulators granted a priority review for an experimental Roche breast cancer drug that in clinical trials added six months to the time before the disease worsened. The Food and Drug Administration will make its decision on whether to approve pertuzumab by June 8, Roche's Genentech unit said on Tuesday. With priority review status, the FDA decides whether to approve a drug ...
Sanofi Loses Court Challenge to FDA’s 2010 Approval of Generic for Lovenox
Sanofi lost a challenge to the U.S. Food and Drug Administration’s approval for a generic version of Lovenox, the blood-thinning drug that had sales of $3.7 billion in 2010.
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