Shares of FibroGen, Inc. (NASDAQ:FGEN) climbed about 3% on Monday after the company said its drug candidate roxadustat has ...

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Company is on track to file the Phase 3 protocol in the fourth quarter of 2025SAN FRANCISCO, (GLOBE NEWSWIRE) -- FibroGen, Inc.

FibroGen (FGEN) announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted roxadustat Orphan ...

Investing.com -- FibroGen, Inc. (NASDAQ:FGEN) stock rose 3% Monday after the company announced that its drug roxadustat received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA ...

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 ...

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

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 ...

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 ...