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40,268 Results for "greenlight biosciences".
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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
·
1 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
Radiopharmaceuticals
FDA’s New Radiopharma Guidance a Greenlight for an Accelerating Space
With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very important for cancer.”
September 2, 2025
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5 min read
·
Dan Samorodnitsky
Press Releases
FDA Greenlights HDT Bio’s First-in-Class HDT-321 for the Prevention of Deadly Tick-Borne Disease
September 22, 2025
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5 min read
Brain cancer
FDA Greenlights Jazz’s Dordaviprone, First New Treatment for Ultra-Rare Brain Tumor
The small molecule drug, acquired by Jazz Pharmaceuticals in its $935 million Chimerix pick-up this spring, is intended for relapsed adult and pediatric patients with H3 K27M mutations.
August 6, 2025
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2 min read
·
Dan Samorodnitsky
FDA
2024 Ends With Greenlights for Merck’s PAH Drug in UK and BMS’ Opdivo Injection in US
Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster.
January 2, 2025
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2 min read
·
Kate Goodwin
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
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5 min read
Deals
GreenLight Biosciences Announces Expiration of Tender Offer Period for Outstanding Shares
GreenLight Biosciences Holdings, PBC (NASDAQ: GRNA) (“GreenLight” or the “Company”) today announced that it is initiating the final steps in closing its previously announced merger with SW MergerCo, Inc. (“Merger Sub”) and SW ParentCo, Inc (“Parent”).
July 20, 2023
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6 min read
Rare diseases
FDA Approves Crinetics’ Once-Daily Acromegaly Treatment
The regulatory greenlight was backed by two Phase III trials that showed normalized growth hormone levels in patients with the rare pituitary condition. It’s the first approval for Crinetics Pharmaceuticals and something CEO Scott Struthers predicted “will transform people’s lives.”
September 25, 2025
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2 min read
·
Dan Samorodnitsky
Genetown
GreenLight Biosciences Releases Inaugural Sustainability Report
GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, today released its inaugural Sustainability Report.
April 12, 2023
·
6 min read
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