Dengvaxia Dengue Vaccine Finally Gets Green Light From CDC’s Advisory Committee
ACIP recommends Sanofi’s vaccine for use in persons 9 to 16 years old with a laboratory confirmation of previous dengue infection who are living in endemic areas. Recommendation comes two years after FDA licensure and following development of improved pre-vaccination screening tests.
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CDC drafting recommendation for Sanofi’s Dengvaxia, setting parameters for required pre-vaccination screening in the absence of tests approved by the US FDA.
Keeping Track: US FDA Approves Sanofi’s Dengvaxia, But Heron’s HTX-011 And Nabriva’s Contepo Fall Short
The latest drug development news and highlights from our US FDA Performance Tracker.
FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.