regulatory approval

News

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.

News

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.

News

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.

News

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).

News

BMS bags a double-quick colorectal cancer approval from FDA

The FDA has approved Bristol Myers Squibb's Opdivo and Yervoy as first-line therapy for patients with a particular form of colorectal cancer.

News

FDA nod broadens use of Brainomix's stroke AI

Brainomix has been granted FDA approval for a new feature for its AI-powered stroke imaging software that could unlock wider use in the US.

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

BMS bags a double-quick colorectal cancer approval from FDA

FDA nod broadens use of Brainomix's stroke AI

Driving the drug discovery pipeline: The value of organ-on-a...

Health Trends 2025: Reimagining What's Possible

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regulatory approval

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