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724,810 Results for "greenlight biosciences inc".
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Press Releases
FDA Greenlights RevBio’s Pivotal Clinical Trial for its Cranial Flap Bone Glue
January 29, 2026
·
3 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
·
1 min read
·
Tristan Manalac
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
·
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
·
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With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very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
·
5 min read
·
Dan Samorodnitsky
Press Releases
Forte Biosciences, Inc. to Present at Upcoming Investor Meetings - February 9, 2026
February 10, 2026
·
1 min read
Press Releases
FDA Greenlights HDT Bio’s First-in-Class HDT-321 for the Prevention of Deadly Tick-Borne Disease
September 22, 2025
·
5 min read
Press Releases
Revelation Biosciences Inc. Announces Exercise of Warrants for $11 Million in Gross Proceeds
January 26, 2026
·
5 min read
Press Releases
Pulse Biosciences, Inc. Appoints Maria Sainz to its Board of Directors
January 9, 2026
·
3 min read
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
·
2 min read
·
Kate Goodwin
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