FDA Shifts to Single Pivotal Trial Requirement for Drug Approvals
FDA plans to require only one pivotal trial for drug approvals instead of two, potentially accelerating development timelines while raising safety and efficacy concerns.
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Oruka Therapeutics Stock Surges on Rival's Mixed Drug Trial Results
Oruka Therapeutics shares jump 30% as analysts predict gains following competitor MoonLake's Phase 3 results.
MoonLake's Sonelokimab Trial Results for Hidradenitis Suppurativa: What Happened?
MoonLake announced Phase 3 results for sonelokimab (VELA trials) in HS. While one trial succeeded using the primary analysis, the other faced challenges due to a high placebo response, leading to a stock downgrade.