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Biotech

Aldeyra dry eye disease decision hit by FDA delay

The delay comes after the regulator sent a draft label for the drug candidate to the company in early December and Aldeyra responded with comments.
Darren Incorvaia Dec 16, 2025 11:55am
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FDA proposes higher fees for ph. 1 trials conducted outside of US

Dec 3, 2025 5:19pm
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Denali's Hunter syndrome drug latest to be hit by FDA delay

Oct 14, 2025 8:09am
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Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am
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FDA delays Omeros' 2nd attempt at transplant drug’s approval

Aug 15, 2025 5:55am
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FDA rejects Capricor’s DMD cell therapy, asks for more data

Jul 11, 2025 9:18am