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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...

Few ODAC Advisory Committee Questions Difficult: Study

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University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficu...

FDA SSDC White Paper Out

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CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.

FDA Extends Review of GSK Multiple Myeloma BLA

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FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with rel...

Longer Drug Review Time Means Fewer Approvals: CBO

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Responding to congressional Democrats, the Congressional Budget Office says a nine-month increase in FDA drug review times would l...