US FDA's Oncologic Drugs Advisory Committee will examine Daicchi Sankyo's acute myeloid lekemia drug quizartinib in the second of two half-day panels for the sponsor.
Daiichi Sankyo Co. Ltd. will have a steep mountain to climb in convincing the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) that the company's acute myeloid leukemia (AML) candidate quizartinib is fit for approval after the agency laid out a slew of efficacy and safety concerns.
ODAC will convene on 14 May to vote on whether the benefits of quizartinib outweigh its risks for the treatment of adults with relapsed or refractory AML which is
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.
