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<![CDATA[The Orphan Drug Act in the Modern Drug Pricing Era]]>
04 Feb 2026 04:03 GMT
… Reduction Act, explores how the Orphan Drug Act, passed in 1983 as … and equity challenges as the Orphan Drug Act intersects with modern drug … incentives for blockbuster drugs, refining orphan drug eligibility, and shifting toward more …
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<![CDATA[FDA Grants Orphan Drug Designation to IFx-2.0 for Advanced Melanoma]]>
03 Feb 2026 02:44 GMT
The FDA has granted orphan drug designation (ODD) to IFx-2. … tumor.2
Clinical Evidence and Orphan Drug Status
The FDA’s decision …
1. TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 …
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<![CDATA[FDA Grants Orphan Drug Status to IFx-2.0 for Advanced Melanoma Care]]>
02 Feb 2026 19:52 GMT
… (FDA) has granted orphan drug designation to the investigational … cancer.
By receiving orphan drug designation, TuHURA Biosciences … release that receiving orphan drug designation highlights IFx … TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2 …
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<![CDATA[Novel Cancer Vaccine Receives FDA Orphan Drug Designation in Cutaneous Melanoma]]>
02 Feb 2026 18:12 GMT
The FDA has granted orphan drug designation (ODD) to IFx-2. … paper.
TuHURA Biosciences received FDA orphan drug designation for IFx-2.0 …
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Tuhura Biosciences Received FDA Orphan Drug Designation For Ifx-2.0 For The Treatment Of Stage IIB To Stage IV Cutaneous Melanoma
02 Feb 2026 14:20 GMT
… Orphan Products Development has granted Orphan Drug Designation (ODD) to IFx-2 … in this patient population."
Orphan drug designation provides seven years of …
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<![CDATA[Nanoscope’s gene therapy, MCO-010 receives Sakigake and Orphan Drug Designations in Japan]]>
31 Jan 2026 01:59 GMT
… Regenerative Medical Product (Sakigake) and Orphan Drug designations for MCO-010 from … designations from the EMA and orphan drug and fast track designations for … FDA. Additionally, it has received orphan drug, fast track, and regenerative medicine …
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<![CDATA[FDA Grants Orphan Drug Designation to Zavabresib for the Treatment of Myelofibrosis]]>
30 Jan 2026 19:29 GMT
The FDA has granted orphan drug designation (ODD) to zavabresnib (OPN- … broader clinical trial evaluation.
“Receiving Orphan Drug Designation for zavabresib in myelofibrosis …
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Caribou Biosciences Announces Late-Breaking Presentations at the 2026 Tandem Meetings of ASTCT® and CIBMTR®
04 Feb 2026 13:00 GMT
… Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for … been granted Fast Track and Orphan Drug designations by the FDA. About …
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RenovoRx Announces Clinical Data Supporting the TAMP™ Therapy Platform will be Presented at the SIO 2026 Annual Scientific Meeting
04 Feb 2026 13:30 GMT
… sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and …
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Biodexa Announces Exclusive License of Otsuka’s OPB-171775, a potent Phase 1 ready Molecular Glue for GIST
04 Feb 2026 13:30 GMT
… -resistant disease4. GIST qualifies for orphan drug designation in major regulatory jurisdictions …