KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has ...
Japan grants orphan drug status to HAE treatment
CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV) has received Orphan Drug ...
FDA review designations: tracking 40 years of innovation
The rising trend mirrors the evolution of the pharma industry in terms of investment and utilisation of novel technologies.
KalVista granted orphan drug designation for sebetralstat by MHLW
KalVista (KALV) announced that Japan’s Ministry of Health, Labour and Welfare, or MHLW, has granted sebetralstat orphan drug designation. The ...
Healio13d
Cour Pharmaceuticals snags orphan drug designation for CNP-104 for the treatment of PBC
The FDA has granted Cour Pharmaceuticals orphan drug designation for CNP-104, a biodegradable nanoparticle in development for ...
Targeted Oncology8d
FDA Grants R289 Orphan Drug Designation in MDS
R289 has gained orphan drug status from the FDA for the treatment of patients with myelodysplastic syndromes. The FDA has ...
The Victoria Advocate13d
Rigel Announces R289 Granted Orphan Drug Designation by the FDA for MDS
"Receiving Orphan Drug designation for R289 supports the development of this therapeutic candidate for the treatment of MDS and highlights the significant unmet medical need that exists for these ...
DutchNews.NL13d
Azafaros granted important regulatory designations and clearance by European authorities for global Phase 3 studies, to be initiated in 2025
Clinical Trial Application for global Phase 3 trials with nizubaglustat in GM1/GM2 gangliosidoses and Niemann-Pick Disease ...
KalVista Announces Orphan Drug Designation And NDA Submission For Sebetralstat In Japan
KalVista Pharmaceuticals, Inc. (KALV) announced Tuesday that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted ...