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Lilly, Merck Extend Combination Drug Pact for Lung Cancer

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Eli Lilly and Merck extend an existing collaboration to evaluate the combination of Lillys Alimta and Mercks Keytruda in a pivotal...

FDA Releases 3 PMR/PMC Backlog Reports

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FDA posts its fifth, sixth and seventh reports on backlogs in postmarketing reports and commitments.

FDA Designates Avelumab Breakthrough Therapy

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FDA says that Merck and Pfizers avelumab is a breakthrough therapy for patients with metastatic Merkel cell carcinoma.

3 Topics at PDUFA 6 Reauthorization Meeting

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FDA makes presentations biomarkers, the benefit/risk framework, and patient-reported outcomes at a PDUFA 6 reauthorization stakeho...

Final Guidance on LDT Oversight Due Next Year: Shuren

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CDRH director Jeffrey Shuren says his Center intends to finalize early next year its guidance on aFramework for Regulatory Oversig...

AngioDynamics Resolves Warning Letter on NanoKnife System

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FDA issues AngioDynamics a close-out letter effectively resolving promotional issues raised in a 2011 Warning Letter involving its...

FDA Posts Approved PMAs

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Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.

WLF Cries Foul on CDC Opioid Prescribing Guideline

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The Washington Legal Foundation calls on the Centers for Disease Control and Prevention (CDC) to withdraw its Draft Guideline for ...

FDA Accepts Sandoz Neulasta Biosimilar Application

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FDA accepts Sandoz regulatory submission for a biosimilar of Amgens Neulasta.

FDA Approves Medtronic MyCareLink Monitor

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FDA approves Medtronics MyCareLink remote pacemaker monitoring system.