The third quarter saw US Food and Drug Administration approvals for two anti-infectives. Pretomanid, indicated for drug-resistant tuberculosis (TB), is only the third TB drug approved over the past 50 years and the first antibiotic to be developed by a non-profit, the TB Alliance. Elsewhere, MSD Merck got the green light for Recarbrio, which is approved for intra-abdominal and for urinary and reproductive tract infections. Two new cancer drugs were approved through the agency’s accelerated approval pathway: Karyopharm’s Xpovio and Roche/Genentech’s Rozlytrek. In early 2020, the FDA will review two sickle cell anemia drugs working through novel mechanisms. Meanwhile, Sarepta’s second exon-skipping antisense drug for muscular dystrophy got pushback from the regulator; its predecessor, Exondys 51, was approved in 2016…

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Fonte: Nat ure Biotechnology | VOL 37 | December 2019 | 1385–1393 | www.nature.com/naturebiotechnology