FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML
The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme
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Tag: Orphan Drug Designation
FDA green light for Fasenra
Currently there are no FDA-approved treatments for eosinophilic oesophagitis.
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Orphan Drug Designation granted for AZ’ Imfinzi
The decision comes hot on the heels of the Phase III CASPIAN trial, which met its primary endpoint.
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FDA orphan drug designation granted for Autolus’ acute lymphoblastic leukemia drug
There will be an estimated 5,930 new cases of ALL and an estimated 1,500 related deaths in 2019.
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EMA confirms path for Diurnal’s Chronocort despite trial failure
The company is on track to submit a Marketing Authorisation Application in the fourth quarter of 2019.
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- Cure Parkinson’s convenes expert panel to assess £2 million combination therapy funding call
- Kygevvi approved in Europe as first treatment for TK2d
- Tozorakimab shows significant benefit in two major COPD trials
- Daratumumab becomes first oncology injectable approved for patient administration
- Laigo Bio completes final close of €17m seed financing round
