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Senate Committee Advances FDA Budget Bill

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The Senate Committee on Appropriations votes to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Develo...

FDA Approves Moderna Covid Vaccine sBLA

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FDA approves a Moderna sBLA for its Spikevax Covid-19 vaccine for children aged six months to 11 years old who are at increased ri...

Rhythm Reports Positive Data on Obesity Drug

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Rhythm Pharmaceuticals reports positive topline results from its Phase 2 trial evaluating bivamelagon in patients with acquired hy...

Exactech Equinoxe Scapula Reconstruction Device Cleared

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FDA clears an Exactech 510(k) for the Equinoxe Scapula Reconstruction System for treating acromial and scapular spine fractures.

FDA Mifepristone Restrictions are Legal: Judge

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A Washington federal judge says FDA acted lawfully in imposing restrictions on the availability of chemical abortion drugs mifepri...

AirLife/Vyaire Recall Infant Heated Wire Circuits

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AirLife and Vyaire recall certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconne...

Trethera Gets Fast Track for Prostate Cancer Drug

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FDA grants Trethera a fast track designation for TRE-515 for treating prostate cancer.

FDA OKs Updated Dosing for Lillys Alzheimer's Drug

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FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known s...

CGMP, Other Violations at Dynamic Blending

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FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over...

Libby Laboratories CGMP Issues

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FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.