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Vytorin

- PMLiVE

Pfizer drug gets speedy FDA review for rare heart failure complication

Tafamidis chalked up a comprehensive win in its phase III trials programme

- PMLiVE

bluebird bags breakthrough status for CALD gene therapy

News comes after impressive data from a phase II/III trial

Roche Basel Switzerland

Another IO knockback as Tecentriq combo fails phase III trial

The bulk of CRC patients with MSS currently look set to be excluded from cancer immunotherapy

- PMLiVE

Morning brief: New biotech launched, Merck and Moderna expand collaboration and more

A rapid round up of pharma, biotech and healthcare news

- PMLiVE

FDA looks to regulate digital tools

US regulator adds new components to digital health plan

Sanofi reception

Sanofi’s latecomer PD-1 gets date for FDA verdict

While Keytruda extends its lead, Sanofi makes a late bid to enter PD-1 space

- PMLiVE

Otsuka finally gets FDA OK for kidney disease drug

Approval at last for rare disease treatment

- PMLiVE

Merck preps regulatory filings for much-needed antibiotic combo

The regimen combines Merck’s own Primaxin with new beta lactamase inhibitor relebactam

- PMLiVE

Rigel and Ultragenyx claim approvals for rare drugs

Tavalisse and Crysvita are set to treat patients with chronic ITP and XLH, respectively

Bristol-Myers Squibb (BMS) building

BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer

Data shows the combo can improve survival compared to Pfizer’s Sutent

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