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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
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
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
·
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With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very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
FDA Greenlights HDT Bio’s First-in-Class HDT-321 for the Prevention of Deadly Tick-Borne Disease
September 22, 2025
·
5 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
FDA
6 FDA Decisions To Watch in Q1 2026
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
January 12, 2026
·
8 min read
·
Tristan Manalac
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
·
2 min read
·
Dan Samorodnitsky
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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