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FDA Blockbuster Drug Approval Plan in October 2021

As of September this year, the US FDA has approved a total of 40 innovative drugs, compared with 40 in the same period last year and 53 in the whole year of last year. In September, the FDA approved 4 models (Exkivity, Tivdak, Qulipta, Livmarli), of which:


Takeda's tyrosine kinase inhibitor Exkivity is the first oral therapy to treat non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation;


Seattle Genetics' tissue factor (TF) targeted drug Tivdak is the first antibody-conjugated drug (ADC) to treat cervical cancer;


AbbVie Qulipta is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine;


Mirum Pharmaceuticals' oral ASBT inhibitor Livmarli is the first drug to treat cholestatic pruritus in patients with Alagil syndrome (ALGS).