Voydeya granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy

Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). It is indicated in Japan in combination with C5 inhibitor therapy when patients have had an…

Read MoreVoydeya granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy

U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy

Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy…

Read MoreU.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy

DUPIXENT® U.S. LABEL UPDATED WITH DATA FURTHER SUPPORTING USE IN ATOPIC DERMATITIS WITH MODERATE-TO-SEVERE HAND AND FOOT INVOLVEMENT

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients…

Read MoreDUPIXENT® U.S. LABEL UPDATED WITH DATA FURTHER SUPPORTING USE IN ATOPIC DERMATITIS WITH MODERATE-TO-SEVERE HAND AND FOOT INVOLVEMENT

European Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous…

Read MoreEuropean Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types