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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...

NDA Filed for Kuras Ziftomenib for Rare Leukemia

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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

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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

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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 ...