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406,572 Results for "novartis gene therapies.rss".
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Approvals
Novartis Expands Spinal Muscular Atrophy Gene Therapy Market With FDA’s Itvisma Greenlight
The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.
November 25, 2025
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3 min read
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Heather McKenzie
Complete response letters
REGENXBIO’s Hunter Syndrome Gene Therapy Fails To Win FDA Nod
The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission for the gene therapy RGX-121.
February 10, 2026
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2 min read
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Tristan Manalac
Gene therapy
In Vivo Is Having a Moment as Cell and Gene Therapy Sector Gathers in San Diego
A recurring theme Tuesday morning at Phacilitate’s Advanced Therapies Week was the quickly emerging potential of in vivo approaches to cell and gene therapy—a trend also reflected in recent investments by Eli Lilly and Regeneron.
February 11, 2026
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4 min read
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Heather McKenzie
Gene therapy
Vertex, CRISPR Set Lofty Goal for Casgevy Gene Therapy as Patient Starts Ramp
Following over a year of slow uptake, Vertex Pharmaceuticals and CRISPR Therapeutics expect Casgevy revenues to nearly triple in 2026, as patient access to the sickle cell disease and beta thalassemia gene therapy grows.
February 13, 2026
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3 min read
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Dan Samorodnitsky
Gene editing
Lilly Leans Into Hearing Loss in $1.12B+ Gene Editing Pact With Seamless
The deal will help bolster Eli Lilly’s growing hearing loss portfolio, which is anchored by the gene therapy AK-OTOF.
January 28, 2026
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2 min read
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Tristan Manalac
Pipeline
Novartis Cuts 6 Early Cancer Candidates, Adds 2 to Refine Oncology Strategy
Despite the Phase 1 cull, CEO Vas Narasimhan on Wednesday maintained that Novartis continues to invest in its early-stage pipeline, looking for deals in the “sub-$2-billion range.”
February 5, 2026
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2 min read
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Tristan Manalac
Earnings
Novartis Sticks With M&A Strategy of Building Early Pipeline, Searching for Near-Launches
Novartis will still be on the lookout for early-stage deals under $2 billion, and later-stage agreements around a product that could reach the market within five years, CEO Vas Narasimhan said Wednesday.
February 4, 2026
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2 min read
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Tristan Manalac
Podcast
Weight Loss Drama Compounds on Heels of Novo, Lilly Earnings, Plus Gene Therapy News
A lawsuit and FDA warning ensued after Hims & Hers launched a compounded version of Novo Nordisk’s new obesity pill, more Big Pharma report earnings—including from weight loss rivals Novo and Eli Lilly—and the gene therapy space sees another rejection.
February 11, 2026
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1 min read
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Jef Akst
Duchenne muscular dystrophy
Sarepta’s DMD Gene Therapy Staves Off Disease Three Years After Treatment
After a spate of patient deaths in 2025 linked to the company’s Duchenne gene therapy, Sarepta shared new data showing benefits of the therapy three years after dosing.
January 26, 2026
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2 min read
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Dan Samorodnitsky
Layoffs
Voyager Throws 30 Staff Overboard After Novartis Sinks Two Programs
Novartis has discontinued two undisclosed programs under its current partership with Voyager, the biotech announced last month. Projects under the deal for spinal muscular atrophy and Huntington’s disease continue to advance.
December 18, 2025
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2 min read
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Tristan Manalac
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