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FDA's Califf on congressional report on Aduhelm controversy; Illumina gives Wall Street bad news

 

Pharmalot Ed Silverman

STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India

By Ed Silverman

Sarah Silbiger/Getty Images

This marks at least the third time in recent years that the FDA cited the same Sun Pharmaceutical facility for manufacturing problems.

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STAT+: An FDA pathway to clear medical devices is putting patients at risk, research suggests

By Matthew Herper

Adobe

New research examines medical devices cleared through the FDA's 510(k) pathway based on existing devices that have had a recall.

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STAT+: FDA's Califf says congressional report on Aduhelm controversy contained 'no surprises'

By Jonathan Wosen

STAT

FDA head Robert Califf made his first public comments following a congressional investigation into the agency’s role in approving Aduhelm.

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STAT+: Illumina, the DNA sequencing giant, gives Wall Street bad news

By Matthew Herper

Adobe

Illumina said its consolidated earnings per share would be in the range of $1.25, dramatically below the expected $2.99 per share.

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STAT+: Hospitals say peak labor costs are behind them

By Bob Herman

Bob Herman/STAT

Rising labor costs have been the main financial concern for hospitals over the past year, but those costs have peaked and gone way down.

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Tuesday, January 10, 2023

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