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- Orphan Drugs

Orphan Drugs Newsletter

New Pleural Mesothelioma Immunotherapy Drug Receives FDA Orphan Drug Status 06 Aug 2025 18:33 GMT
… Drug Administration (FDA) granted orphan drug designation to MVdeltaC, a … some cases. “Receiving orphan drug designation from the FDA … of Oncovita. What FDA Orphan Drug Status Means for Mesothelioma … doesn’t guarantee approval, orphan drug status can make it …
EMA Grants Orphan Drug Designation to Nuvisertib for Myelofibrosis 02 Aug 2025 12:43 GMT
… fast track designation, being granted orphan drug designation from European regulators emphasizes … European Medicines Agency has granted orphan drug designation to nuvisertib (TP- … European-Medicines-Agency-Has-Granted-Orphan-Drug-Designation-to-Nuvisertib-TP- …
Sensorion Finishes Enrolling Patients in Second Cohort of Its Phase 1/2 Trial for Congenital Deafness Gene Therapy SENS-501 08 Aug 2025 05:01 GMT
… M, et al. Sensorion receives orphan drug designation for OTOF-GT for …
Macular Telangiectasia (Mactel) Pipeline Insight 2025: Breakthroughs In Neuroprotection And Retinal Regeneration Reshape The Therapeutic Landscape Delveinsight 08 Aug 2025 03:13 GMT
… retinal health. The FDA granted orphan drug designation to NT-501 in …
Bexmarilimab Responses in High-Risk MDS Continue to Improve 08 Aug 2025 01:59 GMT
… , the FDA granted the agent orphan drug designation for the treatment of … 3. Inside information: FDA grants orphan drug designation for bexmarilimab in MDS …
Vertigo Pipeline Insight 2025: Novel Drug Classes And Central Mechanism Targets Drive Innovation Delveinsight 08 Aug 2025 01:11 GMT
… such as Fast Track and orphan drug status are helping accelerate development …
Minimal Change Disease Pipeline Insight 2025: Advancing Therapies Targeting Podocyte Injury And Immune Dysregulation Delveinsight 08 Aug 2025 01:10 GMT
… some MCD pipeline therapies receiving orphan drug designations and Fast Track status …
BioVie Inc. Announces Pricing of $12 Million Public Offering 08 Aug 2025 00:43 GMT
… liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin …
Progressive Supranuclear Palsy Market On Upward Trajectory During The Forecast Period (2025-2034) With Emerging Immunotherapies Delveinsight 07 Aug 2025 23:27 GMT
… , while regulatory incentives such as orphan drug designations are encouraging innovation in … . AZP2006 has also been granted Orphan Drug Designation by both the US …
INmune Bio (INMB) Q2 Loss Widens 110% 07 Aug 2025 23:33 GMT
… of regulatory approval paths (including orphan drug and accelerated pathways), and robust …

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