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C-Path Seeks Kidney Transplant Biomarker Qualification

[ Price : $8.95]

FDA-backed Critical Path Institutes Transplant Therapeutics Consortium submits the iBox Scoring System for CDERs Biomarker Qualifi...

FDA Participating in Covid Evidence Accelerator

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FDA says it is participating in a new Diagnostics Evidence Accelerator focusing on using real-world data to answer questions about...

Off-Patent, Off-Exclusivity List Updated

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FDA updates its list of off-patent, off-exclusivity drugs for which there is no approved generic product.

MAPP on Need, Review of New REMS

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CDER issues a MAPP with procedures for determining the need for and components of a new REMS for drug products approved through an...

Petition Asks Opioid Boxed Warning Language

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A petition to FDA submitted by a physician asks the agency to include in opioid Boxed Warnings and package inserts HHS language en...

FDA Needs to Regain Public Confidence: Borio

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Former FDA acting chief scientist Luciana Borio tells Barrons FDA leadership needs to work to regain public trust so that people w...

sBLA for Crysvita Approved for Expanded Use

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FDA approves an Ultragenyx Pharmaceutical and Kyowa Kirin supplemental BLA for Crysvita (burosumab) for treating fibroblast growth...

Almiralls Seysara Label Update on Resistance

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FDA approves a label update for Almiralls Seysara (sarecycline) stating that P. acnes strains displayed a low propensity for devel...

FDA Approves Expansion of USGI Weight-Loss Procedure Trial

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FDA approves expanding to 35 subjects a USGI Medical pilot study of its POSE 2.0 endoscopic weight loss procedure.

Harvard, DARPA Screening FDA Covid Drug Effectiveness

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The International Business Times reports that Harvard University and the Defense Advanced Research Projects Agency are collaborati...