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42,299 Results for "greenlight biosciences".
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Approvals
Ultragenyx wins FDA greenlight for first Sanfilippo therapy, priced at nearly $4M
The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month.
September 18, 2026
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3 min read
·
Tristan Manalac
Approvals
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory committee vote in its favor.
August 6, 2026
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3 min read
·
Heather McKenzie
Approvals
Viridian debuts on market with FDA greenlight for thyroid eye disease drug
Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
June 29, 2026
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2 min read
·
Tristan Manalac
Press Releases
Finance & Accounting for Bioscience West debuts in San Diego this December
Discover innovative financial strategies and expert guidance from leading bioscience finance executives at this first-ever West Coast forum.
September 18, 2026
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1 min read
Gene therapy
Rocket’s Gene Therapy Wins FDA Greenlight, Clearing Way for Future Products
While the accelerated approval unlocks only a small market opportunity for Rocket Pharmaceuticals, it will give the biotech a chance to prepare for future product launches, according to Jefferies.
March 27, 2026
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2 min read
·
Tristan Manalac
Press Releases
Swiss Bioscience and OrganTech sign MOU to explore strategic collaboration in hair regeneration in Europe
Swiss Bioscience selected as OrganTech’s preferred strategic partner in Europe for regulatory development, GMP manufacturing, clinical research, and potential commercialization of the conditioned medium technology.
September 23, 2026
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1 min read
Rare diseases
FDA Greenlights First Gene Therapy for Rare Pediatric Disease
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval.
December 10, 2025
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1 min read
·
Tristan Manalac
Press Releases
FDA Greenlights RevBio’s Pivotal Clinical Trial for its Cranial Flap Bone Glue
January 29, 2026
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3 min read
Gene therapy
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently reviewing for a second time. A decision is expected by mid-September.
August 20, 2026
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2 min read
·
Nick Paul Taylor
Mergers & acquisitions
Argenx deepens immuno expertise with $2.2B Forte Biosciences buy
The star of the takeover is Forte Biosciences’ investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
July 27, 2026
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2 min read
·
Tristan Manalac
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