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FDA planning new guidance, hires in cell and gene therapies for...

The FDA plans to hire at least 50 new clinical reviewers tasked with assessing cell and gene therapies to prepare for what the agency...

GE Healthcare partners with Vanderbilt on AI-based immunotherapy guidance and diagnostics

GE Healthcare is teaming up with Vanderbilt University Medical Center to develop more precise cancer immunotherapy diagnostics that use artificial intelligence to predict...

Environmental sustainability should be inherent to dietary guidance – BIOENGINEER.ORG

Society for Nutrition Education and Behavior issues position paper on the importance of including environmental sustainability in dietary guidance, published in the Journal...

Apple failed to warn about China and market saturation, the underlying...

Shira Ovide / Bloomberg: Apple failed to warn about China and market saturation, the underlying conditions for its guidance downgrade, which were obvious...

Apple lowers revenue guidance to $84B, down from $89B to $93B...

Steve Kovach / CNBC: Apple lowers revenue guidance to $84B, down from $89B to $93B projected, says upgrades to new iPhones were weaker...

Apple revises guidance for its fiscal 2019 Q1 downwards due to...

Tim Cook / Apple: Apple revises guidance for its fiscal 2019 Q1 downwards due to weakness in some markets, particularly in China  — ...

FDA finalizes breakthrough device guidance, plugs new safety innovation pathway

The FDA has finalized its guidance on the agency’s breakthrough device designation—and has pitched a new pathway to reward devices that innovate on...

With Gilead and rivals deep in phase 3, FDA unveils draft...

The FDA has published draft guidance on developing NASH drugs that has implications for Gilead and the host of other companies targeting the indication....

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