FDA Advisory Committee Backs Replimune's RP1 Melanoma Therapy in 10-3 Vote After Two Prior Rejections
An FDA panel voted 10-3 that IGNYTE trial results for RP1 plus nivolumab are clinically meaningful, days ahead of an August 2 decision.
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42 articles covering "biotech"
An FDA panel voted 10-3 that IGNYTE trial results for RP1 plus nivolumab are clinically meaningful, days ahead of an August 2 decision.
The Jennifer Doudna-founded CRISPR biotech filed to go public under ticker SCTX as its lead cholesterol therapy remains early in human testing.
AI drug-design startup Chai Discovery raised $400 million at a $3.8 billion valuation, nearly tripling its worth in seven months as Pfizer, Eli Lilly and Novartis sign on.
ARPA-H's new THRIVE program is funding seven teams to build reusable gene-editing platforms for rare pediatric diseases, aiming to move beyond one-patient-at-a-time therapies like the one made for infant KJ Muldoon.
University of Minnesota researchers built SpudCell, a 90-kilobase synthetic cell that feeds, grows and divides, though outside scientists say it is not yet alive.
Base editing knockout of NANOG in human embryos shows it is essential for the epiblast, the tissue that forms the body, arriving alongside a separate disease-gene editing study that has renewed debate over heritable genome editing.
Lonvoguran ziclumeran met its primary endpoint with an 87% reduction in monthly attacks, the first Phase 3 win for an in vivo CRISPR therapy.
Cambridge spin-out DIOSynVax's pEVAC-PS, the first vaccine whose active ingredient was designed entirely by computer, proved safe in 39 volunteers but produced only modest immunity.
Zenas BioPharma's obexelimab met its primary endpoint and all four key secondary endpoints in the Phase 3 INDIGO trial, with results published in NEJM and presented at EULAR 2026.
IGNYTE trial data show 83.5% of responders alive at three years; Replimune plans third BLA resubmission after two FDA rejections.
The FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) on May 22, 2026, making it the first treatment cleared for chronic hepatitis delta virus infection in the United States.
Scribe's ELXR platform silences PCSK9 in the liver without cutting DNA; a single low dose sustained LDL reductions for roughly 18 months in primates.