FDA's NDA And BLA Approvals: Xepi, Admelog, Ixifi

Original new drugs and biologics recently approved by US FDA.

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.

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FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 

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.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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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.