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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 ...

FDA Still Faster than EMA on Cancer Approvals

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A Friends of Cancer Research study update says FDA continues to review and approve novel cancer drugs faster than the European Med...

Sanofi/J&J Scrap E. Coli Vaccine Candidate

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Sanofi and Johnson & Johnson stop the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase ...

Court Rules for FDA in Vanda Label Case

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The DC District Court rules for FDA in a Vanda Pharmaceuticals lawsuit seeking an agency order to revoke the approval of a Teva AN...

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...