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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
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Read More
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More
The FDA and the European Medicines Agency released a draft joint plan this month to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply to rare diseases in general. Read More
The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects. Read More
In response to an increased demand for unit-dose repackaging of solid oral dosage form drugs, the FDA released new draft guidance that would allow extended expiration dating for repackaged unit-doses. Read More