regulatory approval

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Dr Yu Xia, founder, chairwoman, president and chief executive of Akeso

Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Akeso has bagged an FDA approval for its PD-1 inhibitor penpulimab and reported new data on highly-touted PD-1/VEGF bispecific ivonescimab.

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Roche gets EU okay for chest pain algorithm

Roche has claimed a CE Mark in the EU for an AI algorithm that can help doctors decide whether patients with chest pain are having a heart attack.

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FDA clears first migraine DTx from Click Therapeutics

Click Therapeutics' digital therapeutic (DTx) for migraine prevention has been cleared by the FDA, becoming the first treatment of its type in the US.

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After delay, Alzheimer's drug Leqembi gets green light in EU

The EU has approved Eisai and Biogen's Leqembi for a subset of patients with early-stage Alzheimer's disease, more than two years after it was filed.

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BMS gets another FDA okay for Opdivo/Yervoy combo

Bristol-Myers Squibb has claimed its second FDA approval in just a few days for its Opdivo/Yervoy combination, this time in liver cancer.

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Approval moves Columvi earlier in DLBCL treatment pathway

Roche has claimed a first-in-class approval in the EU for Columvi in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Roche gets EU okay for chest pain algorithm

FDA clears first migraine DTx from Click Therapeutics

After delay, Alzheimer's drug Leqembi gets green light in EU

BMS gets another FDA okay for Opdivo/Yervoy combo

Approval moves Columvi earlier in DLBCL treatment pathway

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

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