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Latest From Opko Health

Novel Sickle Cell Treatment Among 13 New Drugs On Track For EU Approval

A first-of-its-kind drug for uterine fibroids and a new monoclonal antibody treatment for COVID-19 are among several new drugs recommended for pan-EU approval this month.

Europe Approvals

EU Crunch Time For 15 New Drugs At Final CHMP Meeting Of 2021

Drugs for COVID-19, Alzheimer’s disease and heavy menstrual bleeding due to uterine fibroids are among the latest products that are this week being considered for marketing approval by the European Medicine Agency’s human drugs evaluation committee, the CHMP.

Europe Drug Review

Four Orphan Drugs Get EU Approval Recommendation

The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.

Europe Drug Review

Keeping Track: US FDA Is Approving JAK Inhibitors Again, Starting With Incyte’s Opzelura; Seagen’s Tivdak Cleared

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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    • ALS Distribuidora Limitada
    • Bio-Reference Laboratories, Inc.
    • Claros Diagnostics Inc.
    • CURNA, Inc.
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    • EirGen Pharma, Ltd.
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    • Transition Therapeutics Inc.
    • Waratah Pharmaceuticals Inc.
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