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FDA Wins Vanda Trade Secret Case

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The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument abo...

FDA Union Sues Trump Over Schedule F

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The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appoin...

Temporary Embargo on FDA Communications

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The Trump Administration places a temporary embargo on external communications by FDA and other government health agencies until p...

FDA Lifts Hold on Cialis Rx-to-OTC Study

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FDA removes clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it li...

Woodcock Joins Friends of Cancer Research Board

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Patient advocacy group Friends of Cancer Research adds former principal deputy commissioner Janet Woodcock to their board of dire...

FDA Fast Track for Heart Imaging Agent

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FDA grants Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain and amyl...

Atara, FDA Agree on Steps to Lift Clinical Holds

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Atara Biotherapeutics says it has reached an agreement with FDA on the steps needed to lift agency clinical holds on its Ebvallo a...

Inflammatix Sepsis Molecular Diagnostic Cleared

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FDA clears an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients...

Multiple Incell Violations Cited

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FDA warns San Antonio, TX-based Incell Corp. about CGMP and other issues in its work as a contract manufacturer of a product deriv...

Amended Sanofi Warning Letter

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FDA issues an amended Warning Letter to Sanofis Genzyme unit in Framingham, MA, about CGMP deviations in its manufacturing of acti...