regulatory approval

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FDA clears sleep apnoea feature for new Apple Watch

Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.

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Apple AirPods get FDA okay for use as OTC hearing aids

It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.

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Emergent Bio gets FDA green light for mpox vaccine

Emergent BioSolutions has been given FDA approval to extend the indications for its smallpox vaccine ACAM2000 to include the prevention of mpox, currently deemed a public health emergency b

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GSK gets EU okay for RSV shot in younger age group

GSK has claimed a new approval for its respiratory syncytial virus (RSV) vaccine Arexvy, currently locked in a battle for market share with rival shots from Pfizer and Moderna, that could l

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Pathogenic Acanthamoeba as seen under a light microscope

EU approves first therapy for acanthamoeba keratitis

The European Commission has approved SIFI's Akantior as the first therapy anywhere in the world for acanthamoeba keratitis (AK), an ultra-rare parasitic infection that can lead to blindness

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Roche gets EU nod for subcutaneous PNH drug PiaSky

Roche's PiaSky has been approved by the European Commission, becoming the first therapy for rare blood disorder paroxysmal nocturnal haemoglobinuria (PNH) that can be given by monthly subcu

FDA clears sleep apnoea feature for new Apple Watch

Apple AirPods get FDA okay for use as OTC hearing aids

Emergent Bio gets FDA green light for mpox vaccine

GSK gets EU okay for RSV shot in younger age group

EU approves first therapy for acanthamoeba keratitis

Roche gets EU nod for subcutaneous PNH drug PiaSky

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory approval

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