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SpringWorks Filing Mirdametinib NDA in 2024

[ Price : $8.95]

After releasing promising clinical data, SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdameti...

Janet Woodcock Retiring in Early 2024

[ Price : $8.95]

FDA principal deputy commissioner Janet Woodcock announces she is retiring early next year after 37 years at the agency.

Managing Legacy Device Cyber Risks

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An FDA-funded report makes recommendations for improving the cybersecurity of legacy medical devices.

Product Testing Alternative Methods

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A new FDA Web page highlights agency efforts to research and implement alternative methods for product testing.

CGMP Violations in Turkish OTC Drug Manufacturer

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FDA warns Tekirdag, Turkey-based Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi about CGMP violatio...

Orphan Status for Lymphoma Therapy

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FDA grants SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-ce...

FDA Punts Merck Cough Drug Data to Panel

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FDA reviewers say that making an assessment on the clinical meaning of complicated data presentations in a Merck NDA resubmission ...

FDA Approves CorMedixs Defencath

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FDA approves CorMedixs Defencath (taurolidine and heparin) catheter lock solution to reduce catheter-related bloodstream infection...

Califf Backs Evidence Generation Report

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FDA commissioner Robert Califf says the time is right to work on implementing recommendations in a Reagan-Udall Foundation report ...

Baxter Recalls Novum IQ Infusion Pump

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Baxter Healthcare recalls its Novum IQ Syringe Infusion Pump because the device may indicate an infusion is complete when it is no...