OBI’s TROP2 ADC OBI-902 has been granted Orphan Drug Designation by the U.S. FDA for the treatment of cholangiocarcinoma, a rare and aggressive cancer with limited treatment options.
#OBIPharma #OBI902 #ADC #OrphanDrugDesignation #Cholangiocarcinoma

www.accessnewswire.com/newsroom/en/...

Q3 Clinical trials round-up: July to September 2025 As the third quarter of 2025 draws to a close, the clinical research landscape has been marked by a surge of promising data and regulatory milestones.

#drugdevelopment #Clinicaltrials #RandD #clinicalresearch #neurodegeneration #regenerativemedicine #clinicaltrialdevelopments #orphandrugdesignation #preclinicaldata #fasttrackdesignation #expandedaccess #FDApriorityreview #clinicalprogress #strategicfunding
zurl.co/jmZiW

Orphelia Pharma explores other pathways for paediatric cancer treatment - PharmaTimes Company seeks new direction after negative CHMP opinion on KIZFIZO

#OrpheliaPharma #KIZFIZO #CHMP #EuropeanMedicinesAgency #CHMPdecision #neuroblastoma #compassionateuse #earlyaccessprograms #clinicaltrials #temozolomideoralsuspension #EarlyAccessAuthorisation #OrphanDrugDesignation #TEMOkidsstudy #BEACONChemostudy #RetroTMZstudy
pharmatimes.com/news/orpheli...

FDA grants Orphan Drug Designation to Ariceum cancer therapy - PharmaTimes Designation follows promising preclinical data and FDA clearance

#OrphanDrugDesignation #ODD #AriceumTherapeutics #systemictargetedradiotherapy#radiopharmaceuticalcancertherapy #radiopharmaceutical #225Acsatoreotide #SmallCellLungCancer #SCLC #SCLCpatients #SANTANA225clinialtrial #theranosticpair #targetedradionuclidetreatment
pharmatimes.com/news/fda-gra...

Zydus announces USFDA Orphan Drug Designation for Usnoflast in ALS treatment - PharmaTimes Orphan drug designation offers development incentives and potential market exclusivity

#Zydus #neurodegenerativedisease #neuroscience #neurology #neurodegeneration #USFDA #FDA #OrphanDrugDesignation #ODD #Usnoflast #NLRP3inhibitor #ALS #amyotrophiclateralsclerosis #ALStreatment #FDAapproval #ZydusLifesciences #Parkinsonsdisease #MultipleSclerosis
pharmatimes.com/news/zydus-a...

Exegenesis Bio's EXG110 Receives Orphan Drug Designation from FDA for Fabry Disease Exegenesis Bio, a global clinical-stage gene therapy company, is thrilled to announce that the U.S.

www.linkedin.com/pulse/exegen...

Exegenesis Bio's EXG110 Receives Orphan Drug Designation from FDA for Fabry Disease

kstrategyand.com/pharma-news

#ExegenesisBio #EXG110 #OrphanDrugDesignation #FabryDisease #GeneTherapy #FDA #RareDiseases #BiotechInnovation #Humanteconomy #Humantech #KStrategyand