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Pfizer Gets Expanded Approval for Adcentris

[ Price : $8.95]

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...

AnaptysBio Reports Positive Data on Arthritis Drug

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AnaptysBio reports positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis.

Max Mobility Recalls Wheelchair Speed Control Dial

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Max Mobility recalls its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board...

Strukmyer Medical CGMP Violations

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FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.

Chengdu Records Review Finds CGMP Deviations

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FDA warns Chinas Chengdu Innovation Pharmaceutical Co. about CGMP deviations in manufacturing active pharmaceutical ingredients.

Court Orders FDA to Restore Gender Web Pages

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DC federal judge John Bates orders FDA and CDC to re-post Web pages and datasets they removed to comply with President Trumps exec...

Change FDA Approach to Antibiotic Approval: Column

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A STAT First Opinion column calls on FDA to focus on how effective new antibiotics are in real-world patients, rather than approvi...