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Gilead Sciences Settlement Helps 49 States

[ Price : $8.95]

Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with Gilead Sciences to resolve cha...

Stakeholder Suggestions for PDUFA Reauthorization

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Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional funding and take steps to imp...

Medline Recalls Craniotomy Kits

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Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable P...

FDA Priority Review for Sprouts Addyi sNDA

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FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal wo...

FDA to Demand New Elevidys Safety Data from Sarepta

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FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the com...

Positive Trial Data on Sleep Apnea Drug

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Apnimed announces positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-d...

FDAs Elsa Hallucinates Confidently: Report

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Gizmodo reports that FDA employees who have used Elsa told CNN the AI tool makes up reports and hallucinates confidently.

Baxter Recalls Mobile Lift Component

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Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attac...

RFK Jr. OKs Directive to Ban Thimerosal in Flu Shots

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HHS secretary Robert F. Kennedy, Jr. approves a new federal directive removing thimerosal, a mercury-based preservative, from all ...

FDA Soliciting CNPV Pilot Interest

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FDA solicits statements of interest in being one of no more than five drug and biologic developers to participate in the initial c...