New Drug Application (NDA) submission on track for January 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome ...

Axsome Therapeutics (AXSM) on Wednesday said it received formal pre–New Drug Application (NDA) meeting minutes from the U.S.

SNB-101 previously received ODDs from the US FDA for small cell lung cancer in July 2023 and pancreatic cancer in February 2024. By receiving an ODD for gastric cancer this time, SN Bioscience expects ...

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 ...

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 ...

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 ...

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 ...

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 ...

If you've ever thought about investing in a company that develops medicines for rare diseases, you've probably recognized the market-creating impact of orphan drug designations. Orphan drugs are ...