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FDA General

Vaccine Skeptic Kennedy Confirmed as HHS Secretary

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

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Human Drugs

Study Sees New Trazodone Adverse Events

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

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Human Drugs

FDA Still Faster than EMA on Cancer Approvals

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

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Biologics

Sanofi/J&J Scrap E. Coli Vaccine Candidate

Sanofi and Johnson & Johnson stop the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase 3 data show that it ...

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Human Drugs

Court Rules for FDA in Vanda Label Case

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

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Human Drugs

Travere Therapeutics Plans Filspari sNDA

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

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Human Drugs

Pfizer Gets Expanded Approval for Adcentris

FDA approves a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating certain adult pa...

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Human Drugs

Bioresearch Monitoring Issue at ISOThrive

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

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Human Drugs

CGMP Deviations at Wuhu Nuowei Chemistry

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

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Medical Devices

Olympus Recalls Bronchoscope Guide Sheaths

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