Drugs

6 Additional National Priority Vouchers Awarded

FDA has awarded six additional vouchers under the Commissioner’s National Priority Voucher pilot program, bringing the number of awards to 15. Upon submission of a complete application, national priority voucher holders are to receive a decision within months, described as a “drastic reduction” of the typical review timeline, contingent upon additional requirements being met by the company, with agency staff reserving the right to extend their review as needed.

“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” says FDA commissioner Marty Makary. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”

These products were selected for the second round of vouchers following external applications and internal nominations from FDA review divisions:

zongertinib (Boehringer Ingelheim’s Hernexeo) for HER2 lung cancer;
bedaquiline (Johnson & Johnson’s Sirturo) for drug-resistant tuberculosis in young children;
dostarlimab (GSK’s Jemperli) for rectal cancer;
Casgevy (Vertex Pharmaceuticals’ exagamglogene autotemcel) for sickle cell disease;
orforglipron (Lilly’s investigational GLP-1 tablet) for obesity and related health conditions; and
Wegovy (Novo Nordisk’s semaglutide) for obesity and related health conditions.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome