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FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the...
FOX 4 Kansas City· 3 days agoThe FDA defines a rare pediatric disease as a serious or life-threatening disease in which the...
Edgewise gets EU orphan drug status for muscular dystrophy drug (NASDAQ:EWTX)
Seeking Alpha· 5 days agoEdgewise Therapeutics (EWTX) has received orphan drug designation from EU regulators for sevasemten...
Edgewise's sevasemten earns EU orphan drug status By Investing.com
Investing.com· 5 days agoEdgewise Therapeutics, Inc. (NASDAQ:EWTX), a biopharmaceutical company focused on muscle diseases,...
FDA grants breakthrough status for Kura Oncology's AML drug candicate By Investing.com
Investing.com· 6 days agoKura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company, has announced that...
Novartis bags paediatric FDA label expansion for Lutathera
Pharmaceutical Technology via Yahoo Finance· 4 days agoQSAM’s lead candidate, CycloSam (samarium-153-DOTMP), has received an orphan drug designation and...
Medicure Receives US FDA Fast Track Designation for MC-1 for PNPO Deficiency
Morningstar· 5 days agoFood and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the prevention or treatment of seizures associated ...
Caliway Announced CBL-514 Phase 2 Study for Cellulite Treatment Met All Primary and Secondary...
WCMH Columbus· 3 days agoCBL-514 is under development for multiple indications, including Cellulite, Local Fat Reduction (currently in Phase 2b), and Durum's disease (currently in Phase 2), which brought Caliway the ...
Kura Oncology Gets Breakthrough Designation For Leukemia Therapy
Market Watch· 6 days agoThe San Diego-based biopharmaceutical company said the U.S. Food and Drug Administration had granted ziftomenib the status as a potential treatment for relapsed/refractory ...
Kura Oncology Receives Breakthrough Therapy Designation for Ziftomenib in NPM1-Mutant AML
Morningstar· 6 days agoFood and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). FDA< ...
KEEP & PANTHERx Rare Forge Innovative Partnership to Advance the Specialty Therapy Experience in the...
FOX 4 Kansas City· 3 days agoAn exciting advancement for the specialty pharmacy industry, KEEP announced a strategic partnership...