Complete Response Letter

Wooden blocks with arrow and error icon Delays and disruptions stop the process critical error concept

Biotech

FDA rejects Aldeyra eye disease candidate for 3rd time

AbbVie has an option agreement for reproxalap, making Aldeyra eligible for a $100 million payment if the FDA approves the drug in dry eye disease.

Gabrielle Masson 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

wheel

Biohaven CEO calls recent FDA decisions 'a systemic problem'

Feb 13, 2026 4:14pm