Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
More from US FDA Performance Tracker
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
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.
More from US Advisory Committees
The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.
The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.