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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...

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.

Olympus Recalls Bronchoscope Guide Sheaths

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Olympus recalls its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the sheath component to s...