Emmaus was unable to answer several questions about its product and was also missing several pieces of data, but FDA's Oncologic Drugs Advisory Committee didn't criticize the sponsor, and instead praised it for paying attention to the largely neglected sickle cell disease.
The largely unmet medical need for a sickle cell disease treatment seemingly allowed the US FDA's Oncologic Drugs Advisory Committee to look the other way on a sponsor that appeared to be unprepared to defend its drug under panel review.
The panel voted 10-3 on May 24 to recommend approval of Emmaus Life Sciences Inc.'s sickle cell disease candidate L-glutamine
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
