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Compounding Violations at Medical Center Pharmacy

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FDA warns Medical Center Pharmacy, Cleveland, TN about insanitary conditions and other violations in its compounding of sterile dr...

Sanders Wants Fair Pricing on Taxpayer-Funded Drugs

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Sen. Bernie Sanders and Rep. Peter DeFazio introduce a rule to require federal agencies to negotiate fair pricing agreements with ...

Praise for BsUFA Statement of Work

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Four stakeholder groups praise FDA efforts in publishing the Biosimilar User Fee Agreement Statement of Work before the 10/1 antic...

Opdivo Accelerated Approval for Colorectal Cancer

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FDA grants Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating certain patients 12 years and older with ...

Celgenes Idhifa Approved for Leukemia

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FDA approves Celgenes Idhifa (enasidenib) for treating adult patients with relapsed or refractory acute myeloid leukemia who have ...

CDRH Oversight of Device Safety Hurts Women: WaPo

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FDA Webview editor Jim Dickinson analyzes a Washington Post article on the Essure contraceptive device and sees an ingrained patte...

FDA Grants AstraZeneca Breakthrough Status for Imfinzi

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FDA grants AstraZeneca and MedImmune a breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locall...

Amgen sBLA for Prolia in Expanded Osteoporosis Use

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Amgen files a supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis.

FDA Clears Immunalysis Fentanyl Immunoassay

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FDA clears an Immunalysis 510(k) for the Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in uri...

FDA Puts Oral Palatal Space Occupying Device Into Class 2

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Federal Register notice: FDA classifies as a Class 2 (special controls) medical device the oral removable palatal space occupying ...