Aug 4, 2008
By:
Chitra Sethi
The FDA has ordered Amgen and Johnson & Johnson to make safety-related changes to the labeling of their erythropoeisis-stimulating agents (ESAs), Aransesp and Procrit.
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Jul 25, 2008
By:
Chitra Sethi
Genentech, Inc., (South San Francisco, CA) has formed a special committee of its Board of Directors to assess the proposal from the Swiss drug-maker Roche (Basel, Switzerland) to take over the remaining shares of the American biotech giant.
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Jun 10, 2008
By:
Chitra Sethi
Health and Human Services Secretary Mike Leavitt has announced that his agency is amending its budget request for FY 2009 to include an additional $275 million for the FDA.
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May 23, 2008
By:
Chitra Sethi
US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.
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Apr 30, 2008
By:
Chitra Sethi
The US FDA has embarked on a multiyear initiative to hire hundreds of individuals with science and medical backgrounds to help meet the agency?s responsibilities to ensure the safety and efficacy of human and veterinary drugs, biological products, medical devices, food, and cosmetics.
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Apr 11, 2008
By:
Chitra Sethi
Takeda Pharmaceutical Company Limited (Osaka, Japan) will acquire Millennium Pharmaceuticals, Inc. (Cambridge, MA), for approximately $8.8 billion through a cash tender offer of $25.00 per share.
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Apr 9, 2008
By:
Chitra Sethi
In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics.
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Mar 6, 2008
By:
Chitra Sethi
The US FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders.
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Feb 28, 2008
By:
Chitra Sethi
On February 22, 2008, the FDA approved two biotech drugs, Avastin (bevacizumab) and HUMIRA (Adalimumab), for additional indications.
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