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- PMLiVE

Vytorin

- 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

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

Keytruda and Opdivo backed for new uses in Europe

CHMP recommendations also include Trumenba, Dinutuximab beta and Refixia

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

Bristol-Myers Squibb (BMS) building

BMS replaces R&D head in wake of Opdivo setbacks

As Merck & Co’s Keytruda gains the lion’s share of the market

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