Six months after court-ordered deadline, FDA hasn’t ruled on major e-cigarette manufacturers’ product applications, advocates say

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Wednesday, March 8, marks six months since FDA failed to meet its court-ordered deadline to rule on all e-cigarette and other new tobacco product manufacturers’ applications. 

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Zymeworks Inc., a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, announced that FDA has cleared the investigational new drug application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers.
FDA granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.