Agency poised to authorize Veru’s NME for COVID acute respiratory distress despite potential efficacy concerns and an unusually small safety database even by EUA standards. FDA assessment highlights continued burden of COVID despite political rhetoric downplaying current impact.
COVID-19 therapeutics still command a lot of US Food and Drug Administration flexibility when it comes to emergency use authorizations, agency advisory committee preview documents released ahead of Veru Inc.’s 9 November panel review for its acute respiratory distress syndrome treatment indicate.
Veru is seeking an authorization for sabizabulin (VERU-111) for the treatment of hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome (ARDS)
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
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.
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.
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.
