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X4 Pharma Gets Priority Review Voucher

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Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining appr...

FDA Qualifies New Ophthalmic Outcome Tool

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FDA qualifies the Assessment of IntraOcular Lens Implant Symptoms patient-reported instrument as a medical device development tool...

Lilly Once-Weekly Insulin Meets Trial Endpoints

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Lilly says its once-weekly insulin efsitora alfa met endpoints in two trials with insulin-nave adults with Type 2 diabetes.

Draeger Anesthesia Device Correction Updated

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FDA updates a Draeger Class 1 recall (device correction) of the Perseus A500 anesthesia workstation after receiving reports that t...

Biogen/Ionis Scrap ALS Drug Development

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Biogen and Ionis Pharmaceuticals discontinue the development of BIIB105 (ION541), an investigational antisense oligonucleotide for...

Drug Nanomaterial Guidance Explained

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CDER review chemist Andrei Ponta discusses the recent guidance on nanomaterials in drugs and biologics on a Center small business ...

Drug Recalls Down, Device Recalls Up: Sedgwick

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The Sedgwick Recall Index for the first quarter of 2024 shows a drop in drug recalls and an increase in medical device recalls.

FDA Import Alert for Some Chinese Syringes

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In an ongoing review of problems with plastic syringes made by some manufacturers in China, FDA says it has imposed an Import Aler...

Accelerated Approval for Amgen Lung Cancer Drug

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FDA gives Amgen accelerated approval for its BLA for Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer in pat...

FDA Updates Covid-Related Device EUAs

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Federal Register notice: FDA announces the issuance of emergency use authorizations (EUAs) for certain medical devices related to ...