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Bioinformatics

FDA Approval

Radiology

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials

Clinical Trials Clinical Trials Trials FDA Approval

United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. It is characterized by progressive fibrosis, lung scarring, and a radiological pattern known as usual interstitial pneumonia, or UIP.

Drugs

Drugs FDA Approval Marketing Containment

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Bridging Innovation & Patient Care: The Growing Role of AI

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The Utility of Liquid Biopsy in Oncology Clinical Trials

United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

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