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FDA outlines efforts to reduce orphan drug designation backlog
SILVER SPRING, Md. — The Food and Drug Administration is committing to eliminate its orphan drug designation request backlog within 90 days and respond to all orphan drug requests within 90 days of receipt. The agency on Thursday outlined its Orphan Drug Modernization plan, which it said is part of a larger effort called the Medical Innovation Development plan modernize and make efficient the FDA’s regulatory tools and policies.
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FDA approves Genentech’s Rituxan Hycela
SILVER SPRING, Md. — The Food and Drug Administration recently approved a new treatment option for patients with three of the most common types of blood cancer. Genentech’s Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection was approved Thursday to treat adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma and previously untreated and previously treated chronic lymphocytic leukemia.XThis ad will auto-close in 10 seconds