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With Phase 3 data in hand, Intellia Therapeutics is seeking approval for its in vivo CRISPR gene editing therapy for hereditary angioedema.
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Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
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Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Corxel will use the fundraising proceeds to advance the oral GLP-1 therapy CX11 through mid-stage development in the U.S., as well as prepare for its Phase III studies.
Growing opposition to vaccines in the U.S., driven by recent government policy changes, makes it difficult to see a return on investment in vaccine development, Moderna CEO Stéphane Bancel said this week.
“I don’t like established science,” ACIP chairperson Kirk Milhoan said in an interview on the Why Should I Trust You? podcast. “Science is what I observe.”
The partnership will allow BMS to advance a T cell–based therapy that is only activated once in the vicinity of a tumor.
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.