Complete Response Letter

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
accelerated

FDA aims for September approval decision for Stealth's drug

Aug 21, 2025 10:15am
end of the road road block shut down closed blocked

FDA snubs PTC's Friedreich's ataxia hopeful with CRL

Aug 19, 2025 10:55am
Start Again written on a chalkboard on wooden table

Stealth Bio submits rare disease application for the third time

Aug 18, 2025 11:08am
question ask wonder who why

FDA denies request to reconsider Stealth's ultrarare disease med

Aug 8, 2025 1:58pm
Image of a neon sign with the word no lit up next to an unlit yes

Replimune's request for melanoma approval rejected by FDA

Jul 22, 2025 8:45am