Policy & Regulation
Rocket Pharmaceuticals receives FDA clearance for gene therapy targeting BAG3-associated dilated cardiomyopathy
30 June 2025 - Late-stage biotechnology company Rocket Pharmaceuticals Inc (NASDAQ:RCKT) announced on Monday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug app...
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
30 June 2025 - Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) on Monday announced plans to advance ARGX-119, a first-in-class agonist antibody targeting muscle-specific kinase (Mu...
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
30 June 2025 - hVIVO plc (AIM:HVO), a specialist in conducting human challenge trials across multiple infectious and respiratory indications, on Monday reported positive topline results from a Phase 2...
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
30 June 2025 - French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that the Ministry of Health, Labour and Welfare in Japan has granted orphan drug designation ...
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
30 June 2025 - Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq:HCM) (AIM:HCM) (HKEX:13) announced on Monday that it has received approval from the China National Medical Products Administra...
Sobi's Gamifant (emapalumab-lzsg) receives US FDA approval to treat macrophage activation syndrome in Still's disease
30 June 2025 - Swedish biopharmaceutical company Sobi (STO:SOBI) announced on Saturday that the US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg) for the treatment of adult...