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Eiger Bio NDA for Rare Preemature Aging Disease

[ Price : $8.95]

FDA approves an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Hutchinson-Gilford Progeria Syndrome and proces...

No Enforcement for Reusing Certain Respirators

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FDA publishes a guidance for using bioburden reduction systems with dry heat to reuse certain filtering facepiece respirators.

Revance BLA Final Review Action Deferred Due to Covid

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FDA defers its review decision on a Revance Therapeutics BLA for daxibotulinumtoxinA for injection, an investigational neuromodula...

Purdue Pharma Pleads Guilty to Fraud, Kickbacks

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Purdue Pharma pleads guilty to three felony counts as part of a plea agreement announced in October.

Merck BLA Filed for Pneumococcal Conjugate Vaccine

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Merck submits a BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and ol...

Biden Impact on FDA Centers/Programs Analyzed

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Three Covington & Burling attorneys analyze how a Biden administration may make its mark on FDA Centers and programs.

Former Insys President Debarred by FDA

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Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a pers...

FDA Wants More CMC Info for Liquidia LIQ861

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An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pu...

FDA Support for U.S.-Mexico-Canada Trade Agreement

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FDA senior trade advisors outline reasons why the new U.S.-Mexico-Canada agreement is better for the agency and public health than...

HHS Withdrawing FDA Compliance Guide on Unapproved Drugs

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Federal Register notice: HHS announces its intent to withdraw FDAs Marketed Unapproved Drugs Compliance Policy Guide, Sec. 440.10...