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FDA IND clearance

Pharma & Biotech

What Actuate Therapeutics, Inc.’s oral formulation push means for pancreatic cancer drug development economics

Actuate Therapeutics, Inc. is advancing oral elraglusib after FDA IND clearance. Discover what this means for pancreatic cancer economics.

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Pharma & Biotech

Scancell’s late-stage push for iSCIB1+ reframes the risk calculus in advanced melanoma trials

FDA clears Scancell’s iSCIB1+ for Phase 3 testing in advanced melanoma. Discover what this means for immunotherapy risk, trial design, and competition.

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Pharma & Biotech

What D3 Bio’s dual KRAS IND clearances reveal about the next wave of targeted oncology

D3 Bio secures U.S. FDA IND clearances for two KRAS programs, advancing G12D monotherapy and G12C resistance combo trials. See what this means for oncology.

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Pharma & Biotech

FDA gives go-ahead to GenEditBio’s first genome-editing trial for TGFBI corneal dystrophy

GenEditBio Limited, a Hong Kong–headquartered clinical-stage biotechnology firm focused on in vivo genome-editing therapies, announced that the United States Food and Drug Administration has cleared its Investigational New Drug application for GEB‑101, a CRISPR-based candidate for TGFBI corneal dystrophy. This regulatory milestone authorizes the launch of the Phase 1/2 CLARITY trial in the United States,

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