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SCOTUS Narrows Agency Deference: Attorney

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Attorney Anne Walsh says regulated companies may cite a recent Supreme Court decision when challenging the notion of judicial defe...

Guide on Drugs for Treating Male Breast Cancer

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Federal Register notice: FDA makes available a draft guidance entitled Male Breast Cancer: Developing Drugs for Treatment.

Inspection Looked at AveXis Manipulated Assay Data

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A recently posted Establishment Inspection Report involving AveXis Zlogensma, which is behind a data manipulation investigation, s...

FDA Antimicrobial Drug Head Joins Regeneron

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CDER Office of Antimicrobial Products director Edward Cox leaves FDA to join Regeneron as regulatory affairs vice president.

Staar Surgical to Begin Trials with Collamer Lens

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FDA gives Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and ...

CGMP Deviations at CTX Lifesciences

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FDA warns Indias CTX Lifesciences about CGMP deviations for active pharmaceutical ingredients.

Kyowa Kirin Parkinsons Add-on Approved

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FDA approves a Kyowa Kirin NDA for Nourianz (istradefylline) tablets as an add-on treatment for patients with Parkinsons disease e...

10 Observations on First Pharma FDA-483

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FDA releases the FDA-483 with 10 observations from an inspection at First Pharma Associates in Spokane, WA.

CGMP, Other Violations in Ningbo Pulisi Inspection

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FDA warns Chinas Ningbo Pulisi Daily Chemical Products Co. about CGMP and other violations in its manufacturing of finished OTC dr...

Lillys Taltz OKd for Ankylosing Spondylitis

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FDA approves Eli Lillys Taltz (ixekizumab) injection 80 mg/mL for treating adults with active ankylosing spondylitis.