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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.
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.
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.
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.
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- ALS Distribuidora Limitada
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- Claros Diagnostics Inc.
- CURNA, Inc.
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- EirGen Pharma, Ltd.
- eXegenics, Inc.
- GeneDX
- Modigene
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- OURLab
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- Prost-Data, Inc.
- Silcon Comércio
- Importacao E Exportacao de Produtos Farmaceuticos e Cosmeticos Ltda.
- Transition Therapeutics Inc.
- Waratah Pharmaceuticals Inc.