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US Congress

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Smart watch epilepsy monitor cleared by FDA

Approval could potentially clear the way for insurers to reimburse its cost

dengue fever mosquito

Takeda gets FDA fast-track status for Zika vaccine

The phase I candidate also has the backing of US federal funding body BARDA

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Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

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AZ and Merck & Co get FDA breast cancer nod for Lynparza

It becomes the first PARP inhibitor to be approved outside ovarian cancer

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FDA’s year-end approvals take annual tally to 46

Rhopressa and Steglatro were among the final medicines licensed last year

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Novo Nordisk gets FDA nod for once-weekly rival to Lilly’s Trulicity

GLP-1 agonist Ozempic approved in the US for type 2 diabetes

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Mylan gets first biosimilar Herceptin OK from FDA

Ogivri approved by US regulators for all of Roche blockbuster's indications

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FDA approves first Apple Watch medical device accessory

Kardia Band functions as a real-time electrocardiogram

AstraZeneca AZ

Setback for AZ as tralokinumab flunks asthma trial

Puts more pressure on AZ’s benralizumab to reach its potential

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AZ gets early FDA green light for Imbruvica challenger

Sets up a marketing battle with Johnson/AbbVie

FDA approves new robotic surgery device

Senhance System backed for colorectal and gynaecological operations

Roche and J&J picked for ‘revolutionary’ digital health pilot

Firms will line up alongside Apple, Fitbit, Samsung and Verily in FDA pre-certification programme

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