FDA Approval Genotype Life Science Regulation 
XTalks
NOVEMBER 9, 2023
The Alinity m high risk (HR) HPV assay is approved for HPV detection and use in routine cervical cancer screening as per professional medical guidelines, explained Abbott in a press release announcing the FDA approval.
XTalks
APRIL 24, 2023
The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.
XTalks
DECEMBER 12, 2023
Importantly, FDA-approved products are now available for these PET imaging applications. The approvals have unlocked the potential to use these highly sensitive agents to assess patient eligibility, determine target engagement and evaluate treatment efficacy for Alzheimer’s disease.
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