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- PMLiVE

buprenorphine

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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

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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

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Novartis gets lung cancer OK for Tafinlar/Mekinist combo

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

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

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

Novartis day

FDA approval for Kisqali sets up showdown with Ibrance

Novartis breast cancer therapy drug has been predicted to reach blockbuster status

- PMLiVE

Trump nominates Gottlieb to head FDA

If confirmed he would take over from previous commissioner Robert Califf

Sanofi reception

Sanofi adds to dupilumab evidence base as US approval nears

FDA to deliver verdict on atopic dermatitis drug

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