Regulatory

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Shots: US FDA granted approval to Pfizer’s BEQVEZ, based on

US FDA Grants Fast Track Designation to Compass Therapeutics’ CTX-009 with Paclitaxel for Previously Treated Metastatic or Locally Advanced Biliary Tract Tumors

US FDA Grants Fast Track Designation to Compass Therapeutics’ CTX-009 with Paclitaxel for Previously Treated Metastatic or Locally...

Shots: Compass received US FDA’s FTD for CTX-009 with paclitaxel to treat me...

Medivir’s MIV-711 Receives FDA ODD and RPDD for Legg-Calvé-Perthes Disease

Medivir’s MIV-711 Receives FDA ODD and RPDD for Legg-Calvé-Perthes Disease

Shots: US FDA granted ODD and RPDD to Medivir’s MIV-711 for treatment of Leg...

Blue Arbor’s RESTORE Neuromuscular Interface System Receives FDA Breakthrough Device Designation & TAP Enrolment

Blue Arbor’s RESTORE Neuromuscular Interface System Receives FDA Breakthrough Device Designation & TAP Enrolment

Shots: US FDA granted BTD designation to Blue Arbor’s RESTORE Neuromuscular...

Ascendis Pharma Receives MHRA Approval for YORVIPATH (Palopegteriparatide) Against Chronic Hypoparathyroidism in Great Britain

Ascendis Pharma Receives MHRA Approval for YORVIPATH (Palopegteriparatide) Against Chronic Hypoparathyroidism in Great Britain

Shots: The MHRA has granted marketing authorization to Ascendis’ Yorvipath (...

CSL Vifor and Travere Therapeutics’ FILSPARI (sparsentan) Received European Commission Approval Against IgA Nephropathy

CSL Vifor and Travere Therapeutics’ FILSPARI (sparsentan) Received European Commission Approval Against IgA Nephropathy

Shots: FILSPARI received conditional marketing authorization (CMA) from European C...

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