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IceCure Medical Appeals De Novo Denial

[ Price : $8.95]

Israels IceCure Medical says it is appealing an FDA denial of the companys de novo classification request for its ProSense cryoabl...

Ascendis Pharma Refiles NDA on TransCon PTH

[ Price : $8.95]

Ascendis Pharma resubmits an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.

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

[ Price : $8.95]

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

Orphan Status for Lymphoma Therapy

[ Price : $8.95]

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

[ Price : $8.95]

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

Smart Womens Choice Consent Decree

[ Price : $8.95]

FDA says the Arizona federal court has approved a permanent injunction against Smart Womens Choice and its CEO to prevent them fro...