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FDA Calendar: These Are the Upcoming FDA Drug Approvals

By the end of this month, two pharmaceutical firms are set to receive a decision on their drug approval applications from the ...
Nasdaq

Mesoblast Secures FDA Orphan-Drug Approval For Ryoncil

(RTTNews) - Mesoblast (MESO, MSB.AX) announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration for Ryoncil (remestemcel-L) for treatment of ...
Wichita Eagle

FDA Approves Orphan-Drug Designation for Jaguar Health’s Crofelemer for Treatment of Diarrhea in Cholera

Crofelemer previously granted orphan-drug designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome and microvillus inclusion disease SAN FRANCISCO, CA / ACCESSWIRE ...
Cure Today

FDA Grants Orphan Drug Status to Cintredekin Besudotox for Glioblastoma

Cintredekin besudotox targets IL-13 alpha-2 receptor in glioblastoma, aiming to spare healthy brain tissue while destroying cancer cells. Orphan drug designation offers benefits like lower fees and ...
Cure Today

FDA Grants Orphan Status to Liquid Glioma Treatment SH-110

SH-110, a liquid medication for glioma, received FDA orphan drug designation, improving treatment options for patients with swallowing difficulties. Orphan drug status offers incentives such as tax ...
Nasdaq

FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results

PRINCETON, N.J., Aug. 18, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to ...

OBI-902 Has Been Granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma

OBI-902 is the first ADC utilizing OBI’s proprietary GlycOBI® glycan-based ADC enabling technology for evaluation of safety and efficacy in patients with Cancer. TAIPEI, TW / ACCESS Newswire / ...
JD Supra

Shutdown Updates, FDA Orphan Drug Leader Reassigned as CMS Issues Orphan Drugs Guidance, FDA to Host Allergen Threshold Meeting, and Commissioner’s National Priority Review ...

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics ...
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Mesoblast (MESO) Gets 7 Years of Orphan-drug Exclusive Approval from US FDA for Ryoncil

Mesoblast Limited (NASDAQ:MESO) is one of the 7 Best ASX Stocks to Buy Now. The company announced that it received 7 years of orphan-drug exclusive approval from the US FDA for Ryoncil® (remestemcel-L ...