Zai Lab Receives FDA Orphan Drug Designation for Zoci
SHANGHAI & CAMBRIDGE, Mass., Aug. 3, 2026 Zai Lab Limited announced that the U.S. Food and Drug Administration (FDA)...
orphan drug designation
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Sumitomo Pharma’s Enzomenib Gains FDA Orphan Drug Status for ALL
MARLBOROUGH, Mass., July 30, 2026 Sumitomo Pharma America announced that the U.S. Food and Drug Administration (FDA) has granted...
Saol Therapeutics Advances SL1009 in FDA Review
ROSWELL, Ga., DUBLIN, Ireland, and HAMILTON, Bermuda, July 28, 2026 Saol Therapeutics has announced that the U.S. Food and...
Co-Diagnostics Advances Ebola Testing Innovation Globally
SALT LAKE CITY, July 28, 2026 Co-Diagnostics, Inc. has announced two significant milestones that strengthen global preparedness against Ebola...
Dasher Neuroscience Advances YA-101 Phase 2 Trial
TAIPEI, July 28, 2026 Dasher Neuroscience Holdings Inc. has successfully completed patient enrollment in its global Phase 2 clinical...
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AstraZeneca’s Sone-Ve Delivers Phase III Survival Breakthrough
CAMBRIDGE, UK, July 27, 2026 AstraZeneca has announced positive high-level results from the global Phase III CLARITY-Gastric01 trial, demonstrating...
Inhibikase Gains FDA Orphan Drug Status for IKT-001 in PAH
WILMINGTON, Del., July 23, 2026 Inhibikase Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted...
Rein Therapeutics Expands Phase 2 RENEW Trial Across Five Countries
Austin, Texas, USA | July 21, 2026 Rein Therapeutics announced that its Phase 2 RENEW clinical trial evaluating the...
Celea Doses First Patient in Phase 3 SURPASS-IPF Trial
BOSTON, July 13, 2026 Celea Therapeutics announced that the first patient has been dosed in the global Phase 3...
Leads Biolabs Secures Priority Review for Opamtistomig
NANJING, China | July 10, 2026 Nanjing Leads Biolabs Co., Ltd. has announced that the Center for Drug Evaluation...
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