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Biologics sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance. 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 granted tentative approval for Merck’s Lusduna Nexvue (insulin glargine injection), as a follow-on basal insulin biologic, a product similar to Sanofi’s flagship Lantus treatment. Read More
The FDA approved the most generic drugs during May and June since it began tallying approvals, according to the agency’s latest report on the generics program — helping Commissioner Scott Gottlieb make good on his early promises to speed generics to market in an effort to lower U.S. drug prices. Read More