Marty Makary

dominoes fall series fail
Biotech

Krystal discontinues melanoma study after FDA's Replimune rebuff

The FDA’s rebuff of Replimune’s melanoma candidate has rippled across the industry, prompting Krystal Biotech to shutter a clinical trial.
Gabrielle Masson Aug 21, 2025 10:50am
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
FDA
Favicon Fierce Pharma

Vinay Prasad is back at the FDA after last month's surprise ouster

Aug 9, 2025 12:22pm
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Favicon Fierce Pharma

FDA taps new CDER chief as acting CBER head after Prasad exit

Jul 30, 2025 1:10pm
delay

FDA delays hit clinical trial launch decisions

Jul 30, 2025 10:29am