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Novartis sNDA for Scemblix Expanded Use

[ Price : $8.95]

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

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23 No-Longer-Marketed ANDAs Withdrawn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...

Kaleo Social Media Post Runs Afoul of FDA

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FDA cites a Kaleo social media post about Auvi-Q (epinephrine injection) because it presented benefit information but failed to in...

Carie Boyd Pharma Hit with FDA-483

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FDA issues Carie Boyd Pharmaceuticals a six-observation Form FDA-483 after inspecting the firms Irving,TX outsourcing facility las...

Alpha Cognitions Zunveyl OKd for Alzheimers

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FDA approves an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimers disease.

Elixir Med. Breakthrough Status for Bioadaptive Implant

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FDA grants Elixir Medical a breakthrough device designation for its DynamX Sirolimus-Eluting Coronary Bioadaptor System for use in...

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 ...