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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...

DoJ Probing Inspire Marketing, Reimbursement

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The Department of Justice has requested information from Inspire Medical as part of a civil probe into its marketing, promotion, a...

FDA Clarifies Compounded GLP-1 Enforcement

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FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.

Genentech Gets New Evrysdi Tablet Approval

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FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.

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...