Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
FDA's NDA And BLA Approvals: Xepi, Admelog, Ixifi
Original new drugs and biologics recently approved by US FDA.
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The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
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The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
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Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.