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FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent - Yahoo Finance
FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent PR Newswire Wed, Oct 23, 2024, 6:02 PM 6 min read ... Read More
FDA Accepts New Drug Application for Pixclara for Glioma Imaging
The FDA has accepted a new drug application for the glioma-imaging agent Pixclara, ... (TLX101-CDx), a glioma-imaging agent, Pixclara manufacturer Telix Pharmaceuticals has announced. The application, ... Read More
FDA launches new priority review voucher program for biopharmas that 'align with national priorities'
The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency. | The FDA is introducing a ... Read More
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for the investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) taletrectinib in the ... Read More
FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA ... Read More
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