With its first US study for a base-edited CAR-T therapy now back on track, Beam Therapeutics is gearing up to begin studies of its first in vivo candidate, BEAM-302, next year in AAT.

The US FDA could approve as many new gene therapies in 2023 as it has in the previous five years. Development in the field has rapidly accelerated, but still faces hurdles.

The two sides of the US public’s perceptions of the biopharma industry are likely to dominate the headlines this fall. Will the industry emerge defined by innovation and hope for better health? Or by massive profits protected by litigation?

Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.