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- PMLiVE

Akynzeo

FDA approves AI-based decision support software

Viz.AI Contact alerts healthcare professionals if a patient is at risk of stroke

- PMLiVE

J&J’s Erleada first US drug for non-metastatic prostate cancer

Drug approved by the FDA on the back of data from the SPARTAN study

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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

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

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

- PMLiVE

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

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

- PMLiVE

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

Rhopressa and Steglatro were among the final medicines licensed last year

- PMLiVE

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

- PMLiVE

Mylan gets first biosimilar Herceptin OK from FDA

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

- PMLiVE

FDA approves first Apple Watch medical device accessory

Kardia Band functions as a real-time electrocardiogram

- PMLiVE

NICE set to reject wider use of Eisai’s Halaven

Issues draft guidance recommending against second-line use in breast cancer

Eisai launches location tracker for dementia patients

Collaborates with Japanese smartphone app network Mamorio on the new tool

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