XTalks

MARCH 3, 2021

Today’s action marks the first FDA approval for a therapy to treat this devastating disease,” said Hylton V. Joffe, MD, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a press announcement from the FDA.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64

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.

FDA Approval 64

FDA Approval HR Genotype Life Science 64

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.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

XTalks

MARCH 1, 2024

This day acts as an opportune moment for professionals in healthcare, life sciences and related fields to highlight the importance of HPV prevention and vaccination as well as the recent advancements in screening and treatment. Cervarix is a bivalent vaccine developed by GSK that received FDA approval in 2009.

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Vaccination Vaccine Life Science FDA Approval 52

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.

Trials 111

Trials Clinical Trials Clinical Trials Genetics 111