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NDA Filed for Kuras Ziftomenib for Rare Leukemia

[ Price : $8.95]

FDA accepts for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for certain adult patients with rela...

Clarity Breast Gets FDA De Novo Authorization

[ Price : $8.95]

FDA gives de novo authorization to Clarity Breast which uses artificial intelligence to make a five-year breast cancer risk predic...

Zeta Given Another Hat at FDA Special Counsel

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FDA deputy commissioner for strategic initiatives Lowell M. Zeta adds Special Counsel for FDA role to his duties.

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

[ Price : $8.95]

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

FDA Budget Proposal Details $400 Million in Cuts

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FDA releases its FY 2026 budget proposal showing that the agencys overall budget would decrease by 4% ($271 million) to $6.8 billi...

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...