Complete Response Letter

dart board miss failure
Biotech

Replimune to lay off staff after 'disappointing' second rejection

Even with additional data and a new team of reviewers, the FDA still found fault with the trials for Replimune's oncolytic virus.
Darren Incorvaia Apr 10, 2026 1:56pm
Wooden blocks with arrow and error icon Delays and disruptions stop the process critical error concept

FDA rejects Aldeyra eye disease candidate for 3rd time

Mar 17, 2026 11:12am
Go sign green light

FDA reconsidering Capricor’s snubbed DMD cell therapy

Mar 10, 2026 11:14am
stack of letters mail envelopes

FDA details Regenxbio rare disease rejection

Mar 3, 2026 12:56pm
big wave over ship in storm

Disc lays off 20% of workforce in wake of FDA rejection

Mar 3, 2026 10:45am
shards of a disc in the air

Disc's rare disease drug hit by FDA rejection

Feb 13, 2026 5:00pm