A provision of the summer’s One Big Beautiful Bill Act bumping a slew of orphan drugs from Medicare price negotiation is ...
The One Big Beautiful Bill Act removed a number of orphan drugs from being subject to price negotiations, and this could cost ...
US Rare Disease Drug Sales Market Opportunity To Surpass USD 190 Billion By 2030 Says Kuick ResearchDelhi, Oct. 16, 2025 ...
The Congressional Budget Office said Monday that a provision in the GOP’s reconciliation bill that widened an exemption for ...
The Congressional Budget Office says exemptions for orphan drugs as part of Medicare price negotiations will cost taxpayers ...
Upon Approval of NDA Quoin Will Receive Seven Years Marketing Exclusivity for QRX003 in the USOrphan Drug Designation previously granted by the ...
GondolaBio, a clinical-stage biopharmaceutical company developing novel medicines for patients living with genetic diseases, today announced that the United States (U.S.) Food and Drug Administration ...
This article outlines common CMC problems that are obstacles that steal momentum and create costly detours in the development ...
An unnamed source clarified that Sandra Retzky has not been fired from the FDA, but it remains unclear where she was ...
The U.S. Congressional Budget Office said on Monday that new exemptions to drug price negotiations for several blockbuster ...
The FDA granted orphan drug designation to cintredekin besudotox for glioblastoma, supporting further research for this aggressive brain cancer.
A local gene therapy pioneer is taking on some of the rarest diseases known to medicine with a new venture spun out from his existing company.