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AstraZeneca Wins Accelerated Approval for Breast Cancer Drug

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FDA grants AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a...

Ionis Pharmas Alexander Disease Drug Approved

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FDA approves Ionis Pharmaceuticals Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patient...

GenAI Devices to See Increased Scrutiny: Law Firm

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A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.

FDA Helping to Increase Supply of Estradiol Patches

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FDA says helping to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty find...

FDA Strengthening Good Clinical Practice Oversight

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Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globaliz...

FDA Wants Botanical Drug Development Input

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FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.

Study Connection Between Foreign Drug Manufacturing and Recalls

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The Senate Special Committee on Aging chairman and ranking member ask the Government Accountability Office to study and assess any...

Prevention Is the Best Counter to CRL Risk: Blog Post

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Consultants RMS suggests ways that companies can reduce the impact and risk of FDA complete response letters.

Food & Drug Legal Icon Peter Barton Hutt Passes Away at 91

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Former FDA chief counsel Peter Barton Hutt passes away at the age of 91.

Boston Scientific Recalls Spinal Cord Stimulator Leads

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Boston Scientific recalls all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience ...