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FDA Grants Orphan Drug Status to Ajax’s AJ1-11095 for Myelofibrosis
12 Dec 2025 12:51 GMT
… Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095, the … meaningful milestone for the program. “Orphan Drug Designation is an important milestone … existing therapies.”
The FDA’s Orphan Drug Designation is intended to encourage …
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<![CDATA[FDA Grants Orphan Drug Designation to Risvutatug Rezetecan for SCLC]]>
11 Dec 2025 20:06 GMT
… ), and anemia (16.1%).
FDA Orphan Drug Designation to Risvutatug Rezetecan for … -targeted antibody-drug conjugate, granted orphan drug designation in small-cell lung … -targeted-antibody-drug-conjugate-granted-orphan-drug-designation-in-small-cell-lung …
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<![CDATA[AJ1-11095 Receives Orphan Drug Designation From the FDA in Myelofibrosis]]>
10 Dec 2025 22:50 GMT
… JAK2 inhibitor–mediated persistence.
“Orphan drug designation is an important milestone … existing therapies.”
AJ1-11095 Receives Orphan Drug Designation in Myelofibrosis: Key … .”
References
Ajax Therapeutics receives orphan drug designation from the U.S …
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Ajax Therapeutics Receives Orphan Drug Designation from the U.S. FDA for AJ1-11095 for the Treatment of Myelofibrosis
10 Dec 2025 13:00 GMT
… Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095 for … lost response (NCT identifier: NCT06343805). “Orphan Drug Designation is an important milestone …
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GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA
10 Dec 2025 07:14 GMT
… Name, risvutatug rezetecan, has received Orphan Drug Designation (ODD) from the US …
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President Trump's Cannabis Decision Is Coming - And Why MMJ International Holdings Wins Either Way
13 Dec 2025 19:43 GMT
…
FDA Approval
Holds INDs and Orphan Drug Designations (the Schedule III requirement …
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<![CDATA[The OncFive: Top Oncology Articles for the Week of 12/7]]>
13 Dec 2025 16:55 GMT
… programs.
The FDA has granted orphan drug designation to risvutatug rezetecan (GSK …
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A Review of Retinopathy Of Prematurity
13 Dec 2025 07:54 GMT
… under priority review and received orphan drug designation for treatment of ROP …
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EU Pharma Package: Parliament and Council reach agreement to modernize EU pharmaceutical legislation - Key takeaways for pharma
12 Dec 2025 23:59 GMT
… —early planning is key.
Optimize orphan drug portfolios: Breakthrough orphan incentives are …
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FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia
12 Dec 2025 23:01 GMT
… patients.
The application was granted Orphan Drug and Priority Review designations.
The …
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