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CGMP Violations at Zhejiang Easyclean

[ Price : $8.95]

FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.

FDA Drops LDT Regulation, Looks to RUOs: Attorneys

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Two Hyman, Phelps & McNamara attorneys say FDA may give research-use-only products greater regulatory scrutiny as a way to maintai...

CBERs Prasad Outlines Rare Disease Goals

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CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoin...

Nubega OKd as Single Agent in Prostate Cancer

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FDA approves a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive pro...

Moderna Wins OK for Next-Gen Covid Vaccine

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FDA approves Modernas next-generation Covid-19 vaccine, Nexspike (mRNA-1283), for use in all adults 65 and older, and individuals ...

Appeals Court Halts Federal Layoffs

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A federal appeals court upholds a freeze on layoffs across FDA and other major federal agencies, rejecting an effort by the Trump ...

Improved Swoop Portable Brain MRI Cleared

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FDA clears a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system.

FDA Launches Elsa AI Tool for Efficiencies

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FDA launches a generative Artificial Intelligence tool called Elsa that is designed to help employees from scientific reviewers t...

Bipartisan Push Seeks Boost in ALS Research

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Congressman Jason Crow (D-CO) leads a bipartisan group of lawmakers in a push to significantly expand federal funding for Amyotrop...

Enhertu Combo Delays Breast Cancer Progression

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A new combination therapy involving AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentechs Pe...