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FDA Alert on Baxter Solution Sets

[ Price : $8.95]

FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled w...

Lykos to Appeal MDMA Drug Rejection

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After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the...

Loper Bright May End FDA Speech Ban: Attorney

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Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new...

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

Supreme Court Could Hit FDA Regulation: FDLI

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A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...

FDA Denies Most Parts of 4 Dental Amalgam Petitions

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FDA denies most elements in four Consumers for Dental Choice petitions seeking additional agency actions to stop or reduce amalgam...

High-Risk Groups Should Avoid Amalgam Fillings: FDA

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FDA says it now recommends that people in seven high-risk categories refrain from exposure to dental mercury amalgam when possible...

Panel Recommends Against Mercury-containing Amalgam

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FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away f...

FDA Requires New Gadolinium Agent Warning

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FDA says it will require a new Warning and other steps to inform patients and healthcare professionals about the risk of gadoliniu...