Grünenthal Receives Dual FDA Designations for Tegacorat in DMD
AACHEN, Germany, July 8, 2026 Grünenthal has announced that the U.S. Food and Drug Administration (FDA) has granted both...
orphan drug designation
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Mesoblast Receives FDA BLA Filing Number for Rexlemestrocel-L
New York, USA & Melbourne, Australia, July 1, 2026 Mesoblast Limited announced that the U.S. Food and Drug Administration...
GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 in IPF
LA JOLLA, Calif., June 18, 2026 GRI Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has...
Novartis Del-Brax Shows Breakthrough Potential in FSHD
BASEL, Switzerland, June 11, 2026 Novartis has announced positive results from the FORTITUDE Phase I/II clinical study evaluating delpacibart...
RedHill’s Opaganib Gains FDA Rare Pediatric Disease Status
RALEIGH, North Carolina, USA & TEL AVIV, Israel – June 9, 2026 RedHill Biopharma has received a significant regulatory...
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Alligator Reports Global Phase 3 Progress for HLX22
LUND, Sweden, June 8, 2026 Alligator Bioscience announced a significant development in the ongoing global Phase 3 clinical trial...
FDA Grants Priority Review to Zydus Therapeutics’ Saroglitazar for Rare Liver Disease
PENNINGTON, New Jersey and AHMEDABAD, India, May 28, 2026 Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, has...
Vanda Gains Japan Orphan Status for Imsidolimab
WASHINGTON, May 27, 2026 Vanda Pharmaceuticals Inc. has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has...
Emalex Ecopipam Phase 3 Tourette Data Published
CHICAGO, Ill., May 26, 2026 Emalex Biosciences announced that Phase 3 clinical data for ecopipam, its investigational dopamine-1 (D1)...
AskBio Expands Rare Disease Pipeline With AB-1009 Pompe Trial Milestone
DURHAM, N.C., May 11, 2026 AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary...
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