MarketPulse

Fast Track designation

7 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Na

NRx Pharmaceuticals Appoints First Chief Commercial Officer Ahead of Ketamine FDA Approvals

NRx Pharmaceuticals names Glenn Tyson as inaugural Chief Commercial Officer, bolstering leadership ahead of anticipated FDA approvals for ketamine products.
NRXPNRXPWBreakthrough Therapy DesignationFast Track designation
GlobeNewswire Inc.GlobeNewswire Inc.··Telix Pharmaceuticals Limited

FDA Accepts Telix's Pixclara NDA for Glioma Imaging; Decision Due Sept. 2026

FDA accepts Telix's Pixclara NDA for glioma imaging with September 2026 decision target. Orphan Drug designation provides competitive advantages.
TLXFDA approvalradiopharmaceuticals
GlobeNewswire Inc.GlobeNewswire Inc.··Greenwich Lifesciences, Inc.

Greenwich LifeSciences Doubles Market for GP2 Cancer Therapy With Expanded Patent Claims

Greenwich LifeSciences expands GLSI-100 breast cancer therapy addressable market by 100% through new patent claims extending to 2045, adding 88,000 potential patients annually.
GLSIGLSI-100FLAMINGO-01
BenzingaBenzinga··Na

Galapagos and Gilead Partner on T Cell Therapy, Splitting $1.7B Ouro Deal

Galapagos and Gilead form binding collaboration on gamgertamig, an autoimmune T cell engager, with Galapagos receiving 50% of Gilead's $1.675B Ouro Medicines acquisition.
GILDGLPGclinical developmentautoimmune diseases
GlobeNewswire Inc.GlobeNewswire Inc.··Telix Pharmaceuticals Limited

Telix Resubmits FDA Application for Brain Cancer Imaging Drug Pixclara

Telix resubmits FDA application for Pixclara, a brain cancer imaging agent with Orphan Drug and Fast Track designations, addressing a regulatory Complete Response Letter.
TLXorphan drug designationradiopharmaceuticals
GlobeNewswire Inc.GlobeNewswire Inc.··Greenwich Lifesciences, Inc.

Greenwich LifeSciences Presents FLAMINGO-01 Trial Data at AACR 2026 Conference

Greenwich LifeSciences presents FLAMINGO-01 Phase III trial data at AACR 2026, showing 80% recurrence reduction. Non-HLA-A*02 arm fully enrolled with 250 patients.
GLSIbreast cancerGLSI-100
BenzingaBenzinga··Prnewswire

Biotech Pipeline Expands Arsenal Against Treatment-Resistant Cancers

Biotech firms advance treatment-resistant cancer therapies across multiple platforms, including oncolytic viruses and cellular immunotherapy, with several candidates achieving regulatory milestones and encouraging clinical data.
IBRXONCYNVCRCATXNUVBcolorectal cancerFDA approval