BioSpace News Archive

Adcomms

First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial

The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.

May 4, 2026

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9 min read

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Tristan Manalac

Opinion

Gene therapy’s evidence problem—lessons from recent FDA decisions

Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.

May 4, 2026

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6 min read

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Jenna DiRito

A scientist with pill bottles in front of FDA headquarters

Regulatory

FDA Action Alert: Argenx, AstraZeneca/Daiichi Sankyo, Biogen/Eisai and Cingulate

The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.

May 4, 2026

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4 min read

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Tristan Manalac

A surreal concept of a regular aluminium ladder pushing through a fluffy cloud on a peach sky background - 3D render

Obesity

Obesity ends oncology’s long reign as top contributor to biopharma pipeline value

In its latest biopharma pipeline report, Deloitte warned that the growing importance of a small pool of potential mega-blockbusters raises the risk of “significant value destruction from a single program failure.”

May 4, 2026

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2 min read

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Nick Paul Taylor

Press Releases

Cairn Surgical Reports Pivotal Trial Results for Its Breast Cancer Locator System

May 4, 2026

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3 min read

Press Releases

Agendia to Present New FLEX Study Data at ASBrS 2026 Confirming the Consistent Performance of MammaPrint + BluePrint Across Diverse Racial Groups in Genomically Basal-Type Breast Cancer