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- PMLiVE

Alkindi

- 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

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

- PMLiVE

Move on Immunomedics board puts Seattle Genetics deal in doubt

Four venBio candidates voted to the board which gives group a majority

- PMLiVE

FDA sets August review date for Teva’s movement disorder drug

Could be first approved treatment for tardive dyskinesia

- PMLiVE

AZ gets US approval for diabetes combo Qtern

Wins licensing for Onglyza/Farxiga dual-therapy after rejection by the FDA in 2015

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