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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...

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.

FDA Seeks Warning on OTC Acetaminophen Products

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Federal Register notice: FDA announces a proposed administrative order to require a warning on Over-the-Counter Internal Analgesic...

Teleflex/Arrow Recall Aortic Catheters

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Teleflex and subsidiary Arrow International recall (Class 1) the Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow Ul...

Getinge Recalls Vaporizer Sevoflurane Maquet Filling

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Getinge recalls (Class 1) its Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration or corrosion within th...

Novavax Amends Covid Vaccine EUA

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Novavax files an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals a...