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Orphan Status for BRAF Inhibitor

[ Price : $8.95]

FDA grants ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients w...

Sage Postpartum Depression Oral Drug Approved

[ Price : $8.95]

FDA approves a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression in adults.

Draft Guide on Cosmetic Registration/Listing

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FDA issues a draft guidance entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry. ...

Astellas Eye Drug Approved by FDA

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FDA approves an Astellas Pharmas Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy secondary to a...

FDA Clears Abbotts Hematology Device

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FDA clears an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts.

Guide on Drug Supply Chain Security

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Federal Register notice: FDA makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements o...

K-TAB Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety o...

Figueroa Permanently Debarred by FDA

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Federal Register notice: FDA permanently debars Raidel Figueroa from providing services in any capacity to a person that has an ap...

Regeneron Prostate Cancer Trial Stops Enrollment

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Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, which is studying the combination us...

FDA Floats AI Modeling to Help Assess Drug Safety

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FDA discusses a new drug safety initiative that aims to develop artificial intelligence models for toxicological endpoints that ar...