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Smart sensor cleared for use with AZ asthma, COPD inhalers

A high-tech device that can monitor medication use and compliance has been cleared by the FDA for use with AstraZeneca’s Airsupra and Breztri inhalers.

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Roche gets EU okay for first HER2-low test kit

Roche has obtained a CE Mark in the EU for a companion diagnostic that can be used to identify patients with HER2-low metastatic breast cancer who may be eligible for trea

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Enhertu gets FDA nod for tumour-agnostic HER2 cancers

The FDA has approved the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu for all HER2-positive solid tumours, in a first for both HER2 inhibitors a

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Carvykti, Abecma move earlier in multiple myeloma treatment

Johnson & Johnson and Legend Biotech’s BCMA-targeted CAR-T therapy Carvykti has been approved by the FDA to treat patients with multiple myeloma after at least one pri

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Basilea Pharmaceutica, ceftobiprole antibiotic

Basilea completes ceftobiprole marathon with FDA approval

Basilea Pharmaceutica will finally be able to bring its antibiotic ceftobiprole to the US market, around 15 years after the drug was first turned down by the FDA.

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$Eko Health and ejection fraction$

FDA clears AI that detects heart failure using a stethoscope

The FDA has cleared an artificial intelligence algorithm that can detect signs of heart failure in seconds using a digital stethoscope during a standard physical exam.

Smart sensor cleared for use with AZ asthma, COPD inhalers

Roche gets EU okay for first HER2-low test kit

Enhertu gets FDA nod for tumour-agnostic HER2 cancers

Carvykti, Abecma move earlier in multiple myeloma treatment

Basilea completes ceftobiprole marathon with FDA approval

FDA clears AI that detects heart failure using a stethoscope

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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