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Jazz Tremor Drug Misses Primary Endpoint

[ Price : $8.95]

Jazz Pharmaceuticals says data from its Phase 2b clinical trial evaluating the efficacy and safety of suvecaltamide in adult patie...

J&J Seeks Tremfya Crohns Indication

[ Price : $8.95]

Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.

De Novo for Onkos Implant Antibacterial Coating

[ Price : $8.95]

FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants.

2023 Trial Diversity Workshop Report

[ Price : $8.95]

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

Guide on ANDA Facility Inspection Readiness

[ Price : $8.95]

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

Animal Drug User Fee Educational Conference

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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