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8 HOURS AGO - Yahoo! News

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Amgen's cancer immunotherapy fails to impress FDA staff reviewers

U.S. Food and Drug Administration staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study. The review comes two days before a panel of FDA advisers votes on whether T-Vec should be approved to treat melanoma. The FDA typically accepts ...

Tags: Amgen's cancer immunotherapy fails to impress FDA staff reviewers,  Amgen Latest News

9 HOURS AGO - Yahoo! News

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FDA staff reviewers cite concerns over Amgen's cancer vaccine data

(Reuters) - The U.S. Food and Drug Administration should not consider an accelerated review of Amgen Inc's marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday, citing concerns over the design and results of a key study. The review comes two days before a panel of FDA advisers votes on whether the treatment, ...

Tags: FDA staff reviewers cite concerns over Amgen's cancer vaccine data,  Amgen Latest News

10 HOURS AGO - Yahoo! News

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FDA staff cite concerns over Amgen's cancer vaccine data

(Reuters) - The U.S. Food and Drug Administration should not consider an accelerated review for drugmaker Amgen Inc's marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday. The review comes two days before a panel of FDA advisers votes on whether the treatment, a cancer-killing virus called talimogene laherparepvec, or T-Vec, should be ...

Tags: FDA staff cite concerns over Amgen's cancer vaccine data,  Amgen Latest News

APR 21, 2015 - Washington Times

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Amgen tops estimates with 51 percent spike in 1Q profit

TRENTON, N.J. (AP) - Amgen Inc. boosted its first-quarter profit by 51 percent, thanks to surging drug sales and ongoing cost cuts designed to free up cash for an unprecedented burst of new product launches. The huge biologic drugmaker on Tuesday beat Wall Street forecasts and raised its profit forecast ...

Tags: Amgen tops estimates with 51 percent spike in 1Q profit,  Amgen Latest News

APR 16, 2015 - Reuters

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U.S. FDA approves Amgen's Corlanor heart failure drug

(Reuters) - U.S. health regulators on Wednesday approved Amgen Inc's Corlanor to treat patients with chronic heart failure, giving the world's largest biotechnology company its first cardiovascular product.

Tags: U.S. FDA approves Amgen's Corlanor heart failure drug,  Amgen Latest News