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Trump Given Investigational Regeneron Covid-19 Cocktail

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President Trump begins taking an investigational drug cocktail from Regeneron after being confirmed to be infected with Covid-19.

FDA Renews, Expands Certara Software

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FDA renews and expands its use of Certara biosimulation software in 11 agency divisions and offices.

Opioid Disorder Effectiveness Endpoint Guidance

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FDA issues a guidance on clinical endpoints to demonstrate the effectiveness of drugs indicated to treat opioid use disorder.

Guidances on Adjuvant Treatments for Renal, Bladder Cancer

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FDA publishes guidances on developing drugs and biologics for adjuvant treatment of two types of cancer.

Guide on Using Physiologically Based Pharmacokinetic Analyses

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Federal Register notice: FDA makes available a draft guidance entitled The Use of Physiologically Based Pharmacokinetic Analyses ...

Draft Guide on QT Prolongation Evaluation Q&As

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Federal Register notice: FDA makes available a draft guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc I...

AndroGel Case Remanded to Pennsylvania Federal Court

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The 3rd Circuit Court of Appeals says a Pennsylvania federal court erred in portions of its decision in a case involving AndroGel ...

Drug Company Profits Push Prices: Reports

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Two House Oversight Committee reports say excessive drug company profits are the primary driver of higher prescription drug prices...

Court Questions Criminalizing Off-Label Promotion

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Attorney Stephen McConnell says the Massachusetts federal court is calling for Congress and FDA to reconsider the statutory and re...

Clinical Hold on Gene Therapy Lifted

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FDA lifts a clinical hold against Solid Biosciences IGNITE DMD Phase 1/2 clinical trial involving SGT-001, a novel adeno-associate...