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OSE Involved in 55 Novel Drug Approvals

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The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic appro...

Vertex NDA for Pain Drug Accepted for Review

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FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderat...

Generic Drug User Fee Rates for FY 2025

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Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.

FDA Clears Varian Microwave Ablation

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

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23 No-Longer-Marketed ANDAs Withdrawn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.