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Biologics

CBERs Prasad Outlines Rare Disease Goals

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

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Human Drugs

Nubega OKd as Single Agent in Prostate Cancer

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

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Human Drugs

NDA Filed for Kuras Ziftomenib for Rare Leukemia

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

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Medical Devices

Clarity Breast Gets FDA De Novo Authorization

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

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Human Drugs

Zeta Given Another Hat at FDA Special Counsel

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

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Human Drugs

Bipartisan Push Seeks Boost in ALS Research

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

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Human Drugs

Enhertu Combo Delays Breast Cancer Progression

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

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FDA General

FDA Budget Proposal Details $400 Million in Cuts

FDA releases its FY 2026 budget proposal showing that the agencys overall budget would decrease by 4% ($271 million) to $6.8 billion beginning 10/1.

Biologics

Moderna Wins OK for Next-Gen Covid Vaccine

FDA approves Modernas next-generation Covid-19 vaccine, Nexspike (mRNA-1283), for use in all adults 65 and older, and individuals aged 12-64 years wit...

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Human Drugs

Appeals Court Halts Federal Layoffs

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