Biotech Stocks Facing FDA Decision In October 2021

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The FDA approved 3 *novel drugs in the month of September, bringing the total number of novel drug approvals so far this year to 39.

Exkivity, the first oral therapy for patients with non-small cell lung cancer who have EFGR exon 20 insertion mutations, Tivdak, indicated for recurrent or metastatic cervical cancer, and Qulipta, the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine are the novel drugs approved in September.

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