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Provide Covid Therapeutics Distribution Info: Califf

[ Price : $8.95]

FDA commissioner Robert Califf calls on the Healthcare Distribution Alliance to give aggregate information to the agency on the di...

2 Consent Decrees Against Supplement Marketers

[ Price : $8.95]

The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC ov...

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

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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.

IceCure Medical Appeals De Novo Denial

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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

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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

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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...