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41,420 Results for "greenlight biosciences".
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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
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
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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
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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
Complete response letters
Published FDA rejections point to manufacturing, data gaps as key stumbling blocks
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
May 11, 2026
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8 min read
·
Tristan Manalac
C-suite
Denali CEO’s ‘greatest professional moment’ arrives as rare disease drug launches
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
April 22, 2026
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7 min read
·
Annalee Armstrong
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
Psychedelics
Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
April 22, 2026
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8 min read
·
Heather McKenzie
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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