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Obama Signs FDA 2012 Spending Bill

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President Obama signs into law a spending measure for FY 2012 that gives the agency $2.5 billion or $50 million (2%) more than FY ...

FDA OKs Removal of Bioscan for Spectrum's NHL Treatment

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FDA approves the removal of a bioscan requirement for Non-Hodgkin lymphoma patients receiving Spectrum Pharmaceutical's Zevalin th...

Former Synthes Officer Sentenced to 9 Months in Prison

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A federal judge sentences former Synthes chief operating officer Michael Huggins to nine months in jail after pleading guilty to a...

Mylan Settles Suit Over Generic Vivelle-Dot

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Mylan says it has settled patent litigation with Novartis Pharmaceuticals involving a Mylan ANDA for a generic copy of Vivelle-Dot...

FDA Extends Review for Takeda Diabetes NDAs

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FDA extends by three months its review of Takeda Pharmaceutical NDAs for the investigational Type 2 diabetes therapy alogliptin, a...

No Surprise: FDA Revokes Avastin Breast Cancer Indication

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In an anticipated move, FDA issues a revocation order on a metastatic breast cancer indication for Genentechs Avastin (bevacizumab...

A Red-Letter Day for FDA and Me

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Washington commentator Robert F. Steeves congratulates commissioner Hamburg and FDA for apparently following his advice in conveni...

NDA for Leukemia-treating Erwinaze Approved

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FDA approves an EUSA Pharma NDA for Erwinaze (asparaginase Erwinia chrysanthemi) to treat certain patients with acute lymphoblasti...

Info on Condom Labeling Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a special controls guidance for natural rubber latex ...

CDER Drug Safety Board Discusses Risperdal Consta

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CDERs Drug Safety Oversight Board reviews reports of needle detachments occurring with Janssens antipsychotic Risperdal Consta.