Business, energy, technology, markets and global industry news from Business News Today

FDA Fast Track Designation

Pharma & Biotech

Coya Therapeutics advances COYA 302 as FDA fast track status raises clinical expectations

Coya Therapeutics’ COYA 302 fast track status raises the stakes for Treg-based ALS therapy. Find out what comes next.

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Pharma & Biotech

Can Cellular Intelligence revive Novo Nordisk’s shelved Parkinson’s cell therapy programme?

Novo shelved the asset, but Cellular Intelligence sees a platform test. Parkinson’s cell therapy now faces its harder commercial trial.

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Pharma & Biotech

4Moving Biotech wins FDA Fast Track for 4P004, but can it finally change the knee osteoarthritis treatment playbook?

4Moving Biotech’s 4P004 won FDA Fast Track in knee osteoarthritis. Read what this means for DMOAD development, trial risk, and regulatory strategy.

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Pharma & Biotech

FDA fast track for Argo Biopharma’s BW-20805 siRNA puts HAE’s next competitive battleground in focus

Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a Shanghai-based clinical-stage RNA interference therapeutics company, has received Fast Track Designation from the U.S. Food and Drug Administration for BW-20805, its investigational small interfering RNA therapy targeting prekallikrein for the prevention of hereditary angioedema attacks. The designation comes as the company runs a global Phase II open-label study

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