Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs ...

The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from ...

Shares of Cero Therapeutics Holdings drew increased retail investor chatter on Tuesday after the company said that the FDA granted orphan drug designation to its lead candidate, CER-1236, for treating ...

Despite both of these facts, the FDA automatically grandfathered Subutex’s 23-year-old orphan drug designation to Sublocade when the latter was approved in November 2017—without requiring ...

Orphan drug designation by the European Medicines Agency (EMA) has a number of advantages, including exclusive marketing authorization for ten years during which time similar products cannot be ...

Getting an orphan designation isn't as simple as just targeting a rare disease. Tim Coté, former director of the FDA's Office of Orphan Products, tackles the most common mistakes companies make “The ...

What the orphan drug designation accomplishes for developers In the U.S., the orphan drug designation confers several benefits. First, companies get a tax credit worth up to 50% of the medicine's ...

Avadel Pharmaceuticals announces Orphan Drug Designation for LUMRYZ to treat Idiopathic Hypersomnia, emphasizing its once-nightly dosing benefit.

Orphan drug designation for cirmtuzumab qualifies Oncternal for certain benefits including tax credits for qualified clinical trials, exemption from certain FDA application fees, and the potential ...

SAN DIEGO, June 24, 2020 /PRNewswire/ -- Viracta Therapeutics, Inc., a precision oncology company targeting virus-associated malignancies, today a ...

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States.