
Stoke Therapeutics Receives FDA Approval to Administer Higher Single Dose of STK-001 in MONARCH Trial for Dravet Syndrome
Stoke Therapeutics' experimental therapy for Dravet syndrome is being tested in the U.S.-based Phase 1/2a MONARCH trial, where a higher single dose of STK-001 will be administered. The U.S. Food and D ...

FDA Grants Orphan Drug Status to Zydus Lifesciences’ ZYIL1 for Treating Cryopyrin-Associated Periodic Syndrome
Zydus Lifesciences has announced that its drug, ZYIL1, has received orphan drug designation (ODD) from the United States Food and Drug Administration (US FDA) for the treatment of Cryopyrin Associated ...

Prestige Biopharma’s PBP1510 Granted Fast Track Designation by FDA for Advanced Pancreatic Cancer Treatment
Prestige Biopharma, a leading biopharmaceutical company, has secured Fast Track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug, PBP1510 (International Non-proprie ...