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41,944 Results for "greenlight biosciences".
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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
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
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
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
·
3 min read
Pain
Lexicon Opens Path to $1B+ Opportunity as FDA Greenlights Phase III for Non-Opioid Pill
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.
January 22, 2026
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2 min read
·
Tristan Manalac
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
·
Heather McKenzie
Genetown
GreenLight Biosciences Secures EPA Registration for New Bioinsecticide, Calantha, Historic Step Towards A Safer and More Sustainable Food System
GreenLight Biosciences (GreenLight Bio) has been granted registration by the U.S. Environmental Protection Agency (EPA) and several states for its groundbreaking Calantha™ product, designed to target and control the highly destructive Colorado potato beetle.
January 4, 2024
·
5 min read
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