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Makary Wins Senate Floor Vote on FDA Confirmation

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A Senate floor vote moves Marty Makary one step closer to becoming the next FDA commissioner.

CGMP Violations at Chinas Yangzhou Sion

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FDA warns Chinas Yangzhou Sion Commodity Co. about CGMP violations in its manufacturing of finished drugs.

AstraZeneca Touts New Tagrisso Data

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AstraZeneca says new study data on Tagrisso (osimertinib) show an improved overall survival trend in certain patients with non-sma...

Exer Labs Illegally Marketing Exer Scan: FDA

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FDA warns Denver, CO-based Exer Labs about illegally marketing its Exer Scan device that has Quality System Regulation violations.

Essure Issues Web Page Updated

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FDA says it received 803 medical device reports on Bayers withdrawn Essure birth control implant in 2024, the lowest number since ...

Maintain, Apply Tabloid Guidance: Petition

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A Buchanan Ingersoll & Rooney petition asks FDA to continue the product-specific guidance restrictions on ANDAs citing Waylis canc...

Lytgobi Web Page False, Misleading: FDA

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The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy presentations in a Web page for i...

Approvable Letter for Sleep Apnea Device

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FDA sends Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apn...

Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J

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Johnson & Johnson says Rybrevant outperformed AstraZenecas Tagrisso in a head-to-head study in the first-line treatment of patient...

Covidien Recalls Shiley Tracheostomy Tube

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Covidien recalls its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns if...