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Klotho’s ALS candidate gains US orphan drug designation
10 Jul 2025 23:02 GMT
… U.S. FDA has granted orphan drug designation to Klotho Neurosciences Inc … /psychiatric Gene therapy FDA Orphan drug
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FDA Grants Orphan Drug Status to STEAP1-Targeting ADC for Gastric Cancer
10 Jul 2025 00:25 GMT
The FDA has granted orphan drug designation to ADRX-0405, an … people in the US.
“Receiving orphan drug designation from [the] FDA is … :
1. U.S. FDA grants orphan drug designation to Adcentrx Therapeutics’ ADRX …
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IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel
09 Jul 2025 21:03 GMT
… Fucaso), has been granted Orphan Drug Designation (ODD) by … existing alternative drugs. For orphan drugs that are “available … Biotherapeutics, stated:
“The Orphan Drug Designation granted to Equecabtagene … guarantee system of orphan drugs in South Korea …
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Bexobrutideg Earns EMA Orphan Drug Designation for Waldenström Macroglobulinemia
09 Jul 2025 20:40 GMT
… Medicines Agency (EMA) has granted orphan drug designation to the orally bioavailable … of patients.
“The EMA’s orphan drug designation for bexobrutideg represents an … Agency grants bexobrutideg (NX-5948) orphan drug designation for the treatment of …
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FDA Grants Orphan Drug Designation to ADRX-0405 for Gastric Cancer
09 Jul 2025 20:24 GMT
The FDA has granted orphan drug designation to ADRX-0405, a … quarter of 2025.2
“Receiving orphan drug designation from FDA is a … 2026.
U.S. FDA grants orphan drug designation to Adcentrx Therapeutics’ ADRX …
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Trump’s ‘Big Beautiful Bill’ revives incentives for orphan drugs
09 Jul 2025 19:22 GMT
… MANUFACTURERS.
CERTAIN PRESCRIPTIONS – KNOWN AS “ORPHAN DRUGS” – WERE EXEMPT FROM THE NEGOTIATION … THEIR INCENTIVES TO STUDY WHETHER ORPHAN DRUGS CAN TREAT MULTIPLE RARE DISEASES … EFFECT IN 20-22 – MULTIPLE ORPHAN DRUG MAKERS CANCELED STUDIES TO SEE …
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Navigating Market Entry Challenges for Orphan Drugs
09 Jul 2025 16:07 GMT
… to the challenge of launching orphan drugs without complete evidence, particularly given …
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US Orphan Drug Market Size Trends FDA Designation By Indication Orphan Drug Sales Clinical Research Insight
09 Jul 2025 13:41 GMT
… On FDA Designated Orphan Drugs In Clinical Trials: > 850 Orphan Drugs
Clinical Trials … On FDA Designated Marketed Orphan Drugs: > 500 Orphan Drugs
Pricing and Dosage Insight … /report-fda-orphan-drug-database The U.S. orphan drug market remains one …
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Fujifilm Pharma's liposomal formulation of gemcitabine FF─10832 receives US FDA's orphan drug designation to treat biliary tract cancer
09 Jul 2025 11:50 GMT
… Administration (FDA) has granted orphan drug designation to Fujifilm’s FF … Fujifilm Pharmaceuticals USA, Inc. “Receiving orphan drug designation highlights the significant unmet … 10850 have also been granted orphan drug designations for cholangiocarcinoma and …
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U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
09 Jul 2025 02:01 GMT
… Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for … future clinical development.
"Receiving orphan drug designation from FDA is a … -releases/us-fda-grants-orphan-drug-designation-to-adcentrx-therapeutics-adrx0405 …