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Partial Hold on BioNTech/Medilink Trial

[ Price : $8.95]

FDA issues a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating BNT...

Keytruda/Chemo Approved for Endometrial Cancer

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FDA approves Mercks Keytruda (pembrolizumab) for use with carboplatin and paclitaxel in adult patients with primary advanced or re...

Guide on Diabetic Foot Infection Drugs

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Federal Register notice: FDA makes available a final guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.

Generic Drug Facility Readiness Inspection Guide

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FDA posts a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA that provides information on how the agenc...

Form 483 Issued to Chugai After Inspection

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FDA gives a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firms Utsunomiya, Tochigi, Japan facilit...

Draft Guide on Vet Safety Studies: Correction

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Federal Register notice: FDA corrects a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entit...

QA Practice for AI Devices is Priority: FDA

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CDRH Digital Health Center of Excellence director Troy Tazbaz says that developing a medical device quality assurance practice for...

Guide on Oligonucleotide Clin/Pharm Considerations

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Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of...

Takeda Soticlestat Studies Miss Primary Endpoints

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Takeda says data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) in Dravet syndrome and Lennox-Gastaut syndrome patie...

Clin-Pharm Considerations for Oligonucleotides Guide

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FDA posts a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.