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Mercks Pneumococcal 21-Valent Vaccine Approved

[ Price : $8.95]

FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and...

Akili OTC App Cleared for ADHD

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FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactiv...

2023 Trial Diversity Workshop Report

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FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.

Guide on ANDA Facility Inspection Readiness

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Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.

Animal Drug User Fee Educational Conference

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Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee E...

Former Device Company CEO Gets 6 Years in Prison

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A New York federal judge orders Stimwave founder and former CEO Laura Perryman to serve six years in jail for medical device healt...

FDA Asks Input on Non-Device Software Functions, Impacts

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FDA asks for input on certain non-device software functions and impacts on patient safety.

Protein Data Bank Aided 100% of Targeted Cancer Drugs: Study

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Academic researchers say all 34 low molecular weight, protein-targeted, antineoplastic agents approved by FDA between 2019 and 202...

Truqap Misses Endpoints in Breast Cancer Trial

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AstraZeneca says its CAPItello-290 Phase 3 trial of Truqap (capivasertib) in combination with paclitaxel in patients with locally ...

FDA WEBVIEW CLOSED 6/19 FOR JUNETEENTH

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FDA Webviews newsroom closes Wednesday 6/19 in recognition of the federal holiday Juneteenth.