Amid Merck supply squeeze, ImmunityBio and Serum Institute snag FDA blessing for BCG expanded access program

The FDA has authorized ImmunityBio’s expanded access program to bring alternative sources of the cancer-fighting bacteria BCG to the U.S. In recent years, Merck & Co., as the biologic's sole manufacturer in the country, has struggled to keep pace with BCG demand.

Feb 19, 2025 - 15:07
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Amid Merck supply squeeze, ImmunityBio and Serum Institute snag FDA blessing for BCG expanded access program
The FDA has authorized ImmunityBio’s expanded access program to bring alternative sources of the cancer-fighting bacteria BCG to the U.S. In recent years, Merck & Co., as the biologic's sole manufacturer in the country, has struggled to keep pace with BCG demand.