GSK plc GSK announced that the FDA has granted Orphan Drug Designation to GSK’227, its investigational B7-H3-targeted ...

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Ajax Therapeutics, Inc ., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that the U.S. Food and Drug ...

As orphan drugs account for an increasing share of drugs approved, they are driving up the cost of drug launches and drug prices. In a new paper, America's Health Insurance Plans analyzes these rising ...

NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global ...

Optum is seeing an increase of new orphan drugs, and expects this trend to continue, if not accelerate, according to a drug pipeline report from the UnitedHealth Group subsidiary. What makes this ...

The Orphan Drug Act (ODA) came into effect in 1983 as a solution to meet an unmet need in the industry. Its success is often projected as an example of how innovative regulatory frameworks can be used ...

Last month, the Food and Drug Administration took the unusual step of admitting it had made a mistake 25 years ago when it granted orphan drug status to an opioid addiction treatment called ...

The Orphan Drug Act of 1983 was passed to promote the development of rare disease treatments. To qualify for incentives under the act, sponsors must first receive “orphan drug designation” from the ...

The IRA requires health plans serving the Part D market to cover all negotiated drugs, and it has been predicted that CMS ...

April 11, 2006 — The US Food and Drug Administration (FDA) has approved orphan drug status for CEP-701 in the treatment of acute myeloid leukemia; the monoclonal antibody ChAglyCD3 for new-onset type ...