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More Accelerated Approval Changes Needed: Kaiser

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The Kaiser Permanente healthcare system calls for FDA and congressional changes to improve the utility of the drug accelerated app...

Astellas Wins Revised Label for Izervay

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FDA approves an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling ...

Petition Seeks FDA Leukeran Actions

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A Buchannan Ingersoll petition asks FDA to impose conditions on ANDAs for generic forms of the cancer drug Leukeran.

Endo Wants Generic Epinephrine Restrictions

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Endo asks FDA not to receive or approve any applications for a generic form of Endos epinephrine products that do not refer to the...

Vaccine Skeptic Kennedy Confirmed as HHS Secretary

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The U.S. Senate votes 52-48 to confirm vaccine skeptic Robert F. Kennedy Jr. to serve as the next HHS secretary.

Study Sees New Trazodone Adverse Events

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Researchers in China say they found several new adverse event signals in their review of 20 years of FDA adverse event reports on ...

Travere Therapeutics Plans Filspari sNDA

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Travere Therapeutics says it will submit an sNDA to FDA for a new indication for its Filspari to treat focal segmental glomerulosc...

Pfizer Gets Expanded Approval for Adcentris

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FDA approves a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treat...

Bioresearch Monitoring Issue at ISOThrive

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FDA warns Healdsburg, CA-based ISOThrive about failing to submit an IND for two clinical trials it sponsored of an investigational...

CGMP Deviations at Wuhu Nuowei Chemistry

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FDA warns Chinas Wuhu Chemistry about CGMP deviations in its manufacturing of active pharmaceutical ingredients.