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An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Read More
An FDA advisory committee voted unanimously Wednesday in favor of the risk-benefit profile for Novartis’ BLA for an innovative new cancer therapy. Read More
The FDA has accepted Amicus Therapeutics’ submission of its rare disease drug for review, a reversal from its decision under the Obama administration. Read More
An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Read More