The US FDA was extraordinarily selective in its use of advisory committees for new drug applications in 2020. It is safe to bet that trend will change under President Elect Biden’s team.
The start of the New Year is a good time for making predictions, so here is one: look for the US Food & Drug Administration to start convening advisory committees more frequently once the new team takes over under President-Elect Joe Biden.
FDA held just 18 reviews of pending new drug applications in 2020, the fewest since 2007. (Arguably it was even...
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.
