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FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzum
January 13, 2017Mylan and Biocon Ltd. have announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a propo -
Aurobindo Pharma gets US FDA nod for its anti-epileptic drug and to acquire Portugal’s Generis for €
January 09, 2017Aurobindo Pharma has been granted final FDA approval to launch a generic version of HQ Specialty Pharma's epilepsy drug levetiracetam, livemint.com reported, Aurobindo Pharma to acquire Portugal’s Generis for €135 million. -
FDA Approves Supplemental New Drug Applications to Include New Data in Product Labels for Synjardy®,
January 06, 2017The U.S. Food and Drug Administration has approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME® trial. -
FDA grants priority review for Bayer’s liver cancer treatment
January 05, 2017The US Food and Drug Administration (FDA) has granted priority review status for the supplemental new drug application for Stivarga (regorafenib, Bayer), as a second line systemic treatment of patients with hepatocellular carcinoma (HCC) in the US.
Pharma Sources Insight July 2025
