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FDA approved two NMEs in October

Agency decisions brought new drugs for hot flashes and IPF, plus the resurrection of Blenrep

November 5, 2025 11:58 PM UTC

FDA approved only two NMEs in October: Jascayd nerandomilast to treat idiopathic pulmonary fibrosis and Lynkuet elinzanetant to treat vasomotor symptoms of menopause.

Boehringer Ingelheim GmbH said Jascayd is the first new IPF treatment in over a decade and the first PDE4B inhibitor approved in the indication. ...