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- PMLiVE

CALD gene therapy

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Bayer bags FDA nod for early prostate cancer drug darolutamide

new competition in the market

- PMLiVE

FDA will maintain the pace, vows Woodcock, but warns of skills gap

Top official unconcerned by dip in approval rate

Battling breast cancer with precision medicine (Part 2)

Dr Mark Moasser treated breast cancer survivor Laura Holmes-Haddad (interviewed in part one) with an innovative precision medicine, which at the time was yet to be approved. Here he gives...

Blue Latitude Health

- PMLiVE

Ex-FDA chief Gottlieb’s quick move to pharma raises eyebrows

Will join Pfizer board

- PMLiVE

Bluebird puts €1.57m price on gene therapy Zynteglo

US biotech pioneering outcomes-based payment in Europe

- PMLiVE

A first for Bluebird and Europe as gene therapy Zynteglo approved

Will product be priced over $1m?

- PMLiVE

One hit, one miss as FDA panel votes on Daiichi’s cancer drugs

Setback for AML candidate quizartinib

- PMLiVE

Bluebird’s myeloma CAR-T safety ‘could support outpatient use’

Expects to file with the FDA next year

- PMLiVE

Lilly to withdraw Lartruvo, a first for accelerated approval failures

Existing patients can use access programme

- PMLiVE

Bad news for BMS as Keytruda kidney cancer combo approved

Opdivo and Yervoy combination will be squeezed

- PMLiVE

Gottlieb signs off with flair – and pledge of further drug price commentary

Highlights issues of insulin prices and competition

- PMLiVE

Bluebird plays down report of EU gene therapy approval

Charity says Zynteglo (LentiGlobin) has already achieved a conditional marketing authorisation

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