BioSpace News Archive

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Manufacturing

FDA pilots AI-informed one-day facility inspections

Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.

May 7, 2026

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2 min read

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Nick Paul Taylor

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FDA

FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit

The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.

May 7, 2026

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3 min read

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Heather McKenzie

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Duchenne muscular dystrophy

Entrada crashes as Duchenne therapy comes in ‘below expectations’ in early study

Entrada Therapeutics saw a 2.36% dystrophin increase in patients treated with its oligonucleotide asset—a number that fell short of the company’s prior guidance of a double-digit improvement.

May 7, 2026

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3 min read

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Tristan Manalac

Press Releases

LiquidCell Dx Announces Nature Paper Showing that Liquid Biopsy of the Tumor Microenvironment Powerfully Forecasts Therapy Response

May 7, 2026

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5 min read

Press Releases

Vaxcyte Reports First Quarter 2026 Financial Results and Provides Business Update