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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

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Otsuka finally gets FDA OK for kidney disease drug

Approval at last for rare disease treatment

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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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Alkermes slumps as FDA turns down depression drug

The drug needs to be supported with additional trials and a bioavailability study, says US regulator

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Seattle Genetics claims key US approval for Adcetris

Becomes the first new treatment for advanced Hl in more than 40 years

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FDA approves another home genetic testing service

23andMe’s kit will check for an increased risk of certain cancers developing

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AbbVie’s uterine fibroids drug aces second phase III trial

An FDA verdict is expected in the US in the coming weeks

Bristol-Myers Squibb (BMS) building

BMS gets OK for monthly Opdivo dosing

Analysts predict the new dosing schedule could see the pharma giant win market share

Celgene building

FDA turns down Celgene’s filing for multiple sclerosis drug

The application needs additional pharmacology information according to the US agency

FDA approves AI-based decision support software

Viz.AI Contact alerts healthcare professionals if a patient is at risk of stroke

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