Six first-in-class approvals in August
Early September approvals include Ionis’ Zanvastro for Alexander disease, AZ’s Etcamah for breast cancer
August was a banner month for first-in-class drug approvals.
Most of the fanfare among these first-in-class drugs went to RAS(ON) inhibitor Rasonque daraxonrasib from Revolution Medicines Inc. (NASDAQ:RVMD), which was approved only 40 days after submission under the Commissioner’s National Priority Review Voucher (CNPV) program. It was not the only new cancer mechanism approved — Zenbexus iberdomide from Bristol Myers Squibb Co. (NYSE:BMY) became FDA’s first cereblon E3 ligase modulatory drug (CELMoD) to be approved. Zenbexus received accelerated approval to treat relapsed multiple myeloma. ...
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