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Food and Drug Administration (FDA)

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Biotech

After delay, Coya receives FDA go-ahead for phase 2 ALS trial

The agency previously alerted Coya that it would miss the July 30 deadline for a decision on the IND application due to limited resources.
Darren Incorvaia Aug 25, 2025 11:04am
Clock in front of the subway

FDA draft recommends all cancer trials collect OS data

Aug 20, 2025 10:59am
clock delay wait time alarm

Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am
delay FDA delay

Another biotech hit with FDA delay for ALS asset

Aug 18, 2025 11:01am
plan B fail reroute road path trail miss

FDA delays Omeros' 2nd attempt at transplant drug’s approval

Aug 15, 2025 5:55am
Mice playing around tubes in a rack in the lab

Big Pharma-backed program seeks future beyond animal testing

Aug 1, 2025 5:00pm

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