Complete Response Letter

door exit shut close end walk away
Biotech

F2G, Shionogi prep regulatory push after antifungal passes ph. 3

F2G and Shionogi have released phase 3 data for olorofim demonstrating its non-inferiority compared with an existing drug for invasive aspergillosis.
Will Maddox Jun 18, 2026 12:01am
dart board miss failure

Replimune to lay off staff after 'disappointing' second rejection

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