Court ruling in orphan drug lawsuit reframes outlook on ...
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Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same drug for the same indication, unless the ... Healio News Rheumatology PracticeManagement
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- 1Orphan Drug Exclusivity Keeps Biosimilars Off the Market ...
Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says ... Investigators found that...
- 2ORPHAN DRUGS IN THE UNITED STATES: - National ...
development in the rare disease space by offering grants, tax credits for clinical trial costs, w...
- 3Market exclusivity: orphan medicines | European Medicines ...
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, th...
- 4Newly passed House bill could close orphan drug loophole ...
The FDA can grant seven years of market exclusivity to a drug if it's intended to treat a conditi...
- 5Orphan drug - Wikipedia
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because the...