Biotech Stocks Facing FDA Decision In November 2021

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The FDA approved only 1 *novel drug in the month of October, bringing the total number of novel drug approvals so far this year to 41.

Tavneos, approved as an adjunctive treatment for ANCA-associated vasculitis, is the lone novel drug approval of the month. Developed by ChemoCentryx Inc (CCXI), Tavneos, which will be priced at a wholesale acquisition cost of $150,000–$200,000, is expected to be launched in the coming weeks.

*Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.