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 ...
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 ...
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.
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 ...
Business Wire4d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
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 ...
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 ...
Rigel Pharmaceuticals Gets FDA Orphan-Drug Designation for R289
Rigel Pharmaceuticals on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its proposed R289 treatment for myelodysplastic syndromes, a group of rare blood cancers ...
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 ...