EMA Positive Opinion Grants Orphan Drug Hope for CTCL Treatment
Dateline – November 17 2025 | Lund, Sweden BioInvent International AB (“BioInvent”), a clinical-stage biotech company focused on novel...
orphan drug designation
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Precision NeuroMed Earns FDA Orphan Drug Status for GBM Therapy
REDWOOD CITY, Calif., Oct. 7, 2025 — Precision NeuroMed (PNM), a clinical-stage biotechnology company advancing next-generation drug delivery technologies...
FDA Grants ODD and UK CTA Clears Gene Therapy for Stargardt
MILAN, Italy, Oct. 2, 2025 — AAVantgarde Bio announced that its investigational gene therapy AAVB-039 has received Orphan Drug...
FDA Grants Orphan Drug Designation to Utidelone for Pancreatic Cancer
SAN FRANCISCO, Sept. 25, 2025 — Biostar Pharma’s core anticancer drug Utidelone has been granted Orphan Drug Designation (ODD)...
Orphan Designation for ADPKD Treatment Marks Rare Disease Breakthrough
MONMOUTH, N.J., Sept. 18, 2025 A new investigational therapy, JD-004, has received Orphan Drug Designation (ODD) from the U.S. Food...
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Zhimeng Biopharma Wins Approval to Launch Phase 2 Epilepsy Trial
Shanghai, China – September 11, 2025 – Shanghai Zhimeng Biopharma, Inc. today announced that its investigational therapy CB03-154, a...
FDA Issues Complete Response Letter for SL1009 in PDCD Treatment
ROSWELL, Ga., September 8, 2025 — Saol Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has...
Sanofi’s Wayrilz Approved in the U.S. as First BTK Inhibitor for Immune Thrombocytopenia
Sanofi has secured U.S. FDA approval for Wayrilz (rilzabrutinib), marking the first Bruton’s tyrosine kinase (BTK) inhibitor approved for...
NATCO Launches Generic Bosentan Tablets for Oral Suspension in the U.S. with 180-Day Exclusivity
Hyderabad, India, August 20, 2025 – NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) today announced the launch of...
SmartLabs and Sonrai Form Exclusive AI Partnership to Accelerate Precision Medicine and Scientific Discovery
SmartLabs and Sonrai Analytics today announced a global strategic alliance to integrate Sonrai’s next-generation AI platform, Sonrai Discovery, into...
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