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FDA Clears Varian Microwave Ablation

[ Price : $8.95]

FDA clears a Varian 510(k) for its IntelliBlate microwave ablation system, intended for ablating soft tissue.

Require Nasal Spray Food Studies: Aquestive

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Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.

Amazon, Walmart Illegally Sell Chemical Peels

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FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.

FDA Denies Public Citizen Tramadol Petition

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Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administra...

Novartis sNDA for Scemblix Expanded Use

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FDA accepts for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly ...

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

Colon Cancer Blood Test Approved

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FDA approves Guardant Healths Shield blood test for colon cancer screening in adults 45 years of age and older who are at average ...

Pharmacy Compounding Panel Renewed

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Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.

23 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they notified the agency that the produ...

AstraZeneca Reports Favorable Calquence Data

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AstraZeneca says data from its Phase 3 AMPLIFY trial showed that Calquence (acalabrutinib) in combination with venetoclax showed f...