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- PMLiVE

Prescription Digital Therapeutics

- PMLiVE

Neurocrine bags FDA approval for first tardive dyskinesia drug

Ingrezza edges ahead of Teva’s rival drug Austedo

- PMLiVE

FDA changes its mind on 23andMe’s genetic testing kits

Approves a home test kit for gene sequences related to diseases like Alzheimer’s and Parkinson’s

- PMLiVE

AbbVie and J&J file first non-cancer use for Imbruvica with FDA

Seeks FDA approval to treat GVHD patients

- PMLiVE

BMS closes in on colorectal cancer indication for Opdivo

Gains US priority review to treat patients with dMMR or MSI-H colorectal cancer

- PMLiVE

FDA approves Teva’s Huntington’s disease drug at second attempt

Austedo will treat fatal degenerative disorder chorea

- PMLiVE

Novartis gets lung cancer OK for Tafinlar/Mekinist combo

It can now be used to treat BRAF V600E-positive NSCLC patients in Europe

- PMLiVE

Danish Medicines Agency urges caution on health app use

Says mobile applications on their own cannot make a diagnosis

Novartis day

Novartis files CAR-T therapy in US, with swift review

CTL109 candidate gets FDA priority review status

- PMLiVE

Tesaro joins PARP parade with US approval of Zejula

Unlike its rivals Zejula doesn’t require a BRCA mutation in patients before use

- PMLiVE

Making digital health personal

What makes a tool successfully support adherence and deliver value-based care?

AstraZeneca AZ

FDA turns down AZ’s ZS-9 once again on manufacturing issues

The regulator says it can resubmit the application once deficiencies are tackled

Sanofi to develop a mobile app for insulin patients

Will work with therapeutic companion software company Voluntis

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